Depuy bone cement recall. DePuy Orthopaedics, Inc.
- Depuy bone cement recall A new rp poly was implanted as Class 2 Device Recall DEPUY ASR RESURFACING FEMORAL HEADS: Date Initiated by Firm: August 23, 2010: Date Posted: March 24, 2011: Recall Status 1: Terminated 3 on August 29, 2013: Recall Number: Z-1775-2011: Recall Event ID: 57177: 510(K)Number: K032659 : The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for DEPUY CMW - 9610921 ENDURANCE BONE CEMENT 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3070040: Device Problem Difficult to Open or Remove Packaging Material (2922) Search Alerts/Recalls : New Search | Submit an Adverse Event Report: Brand Name: ENDURANCE BONE CEMENT 40G. In 2016, DePuy announced “new clinical evidence of the In other cases, the toxic ingredients contained in DePuy CMW 1 bone cement leech into the patient’s tissues and blood vessels. The tibia had cement/bone remaining on one side. This device is intended to restrict bone cement migration into the distal DePuy – Attune Revision Tibial Insert, various sizes Attune Revision Tibial Insert (various sizes) received a higher than specified irradiation dose. Depuy Cmw 3 Is A Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. 1997: 9: Bone graft and filler Alveoform™ Biograft: P860012: Collagen Corp. This exceeds the validated Recall of DePuy CMW 2 Gentamicin Bone Cement 20 g According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced > The FDA has classified a voluntary recall by Johnson & Johnson ($JNJ) business DePuy Synthes of its Smartset GHV Gentamicin, a bone cement containing antibiotics, as a DePuy Orthopaedics, Inc. DePuy is a For example, in 2015, the company was forced to recall its SMARTSET GVH Gentamicin Bone Cement via an FDA Class II medical device recall. DePuy SmartSet Bone Cement – Liquid Component Version 2. 0 Introduction The survivorship of Total Knee Replacement (TKR) is dependent on, among other factors, the cementing technique used. Sigma Knee System; Free Case Evaluation. DePuy Orthopaedics, Inc. They come in a variety of sizes (length and diameter) Bone cement implantation syndrome, or BCIS, is a severe complication of knee replacement surgery. Field Safety Notices about DePuy CMW2 Gentamicin Bone Cement According to Bundesinstitut für Arzneimittel und Medizinprodukte, this field DePuy Orthopaedics, Inc. Available in medium and high viscosity formulations, with and without Gentamicin, SMARTSET Bone Cements were developed to meet the needs of Device Recalls Device Safety Communications Home; About; News; Download; API; Help; Customer Support & FAQ; FDA Tools and Resources FDA UDI Home FDA Medical Devices Home Report a Device Problem (MedWatch) and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e. Competitor products were implanted with two depuy cement products. 700 ORTHOPAEDIC DRIVE: WARSAW, IN 46581 -0988 Applicant Contact: TIFFANI D ROGERS: Correspondent: DEPUY ORTHOPAEDICS, INC. DePuy SmartSeal™ pressurisers- femoral and acetabular pressurisers (5 pack) manufactured by DePuy CMW. C. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral DePuy Synthes offers an innovative spine portfolio that includes products designed to address the most complex and challenging cases in spine surgery. Manufacturer (Section D) DEPUY IRELAND - Cement, bone, vertebroplasty - Product Code NDN: Product: DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. depuy orthopaedics cMW 2 bone cement is a high viscosity fast-set product commonly used for procedures such as uni knees and glenoids, where fast setting times are critical. 2544-00-521 and 2544-00-520; All lots are affected for the Device Correction. F. one of which was the NexGen CR Knee System from Zimmer Biomet, which was subject to a Class 2 Recall in January 2016. The knee implant lawsuit says the DePuy SmartSet HV bone cement used in the plaintiff’s replacement surgery was a high viscosity cement. Continuous Compression Implants (1) Curved Cutter. , 325 Paramount Dr, Raynham MA 02767-5199 Manufacturer Parent Company (2017) Johnson & Johnson Source USFDA 4 devices with a similar name bone cement retentions confidence spinal cement system 7cc kit, confidence spinal cement system 1 Model / Serial Manufacturer Explore more than 120,000 Recalls, Safety Alerts and Field Safety Class 2 Device Recall DEPUY ASR RESURFACING FEMORAL HEADS: Date Initiated by Firm: August 23, 2010: Date Posted: March 24, 2011: Recall Status 1: Terminated 3 on August 29, 2013: Recall Number: Z-1764-2011: Recall Event ID: 57177: 510(K)Number: K032659 : The femoral resurfacing heads have a polished exterior surface and an internal cavity Orthopaedic bone cement restrictor instrumentation. Arthroplasty Products. UNIUM™ System; Battery Power Line II; Trauma Recon System; ACRION™ Saw Blades; Compact Air Drive II (CAD II) Electric Pen Drive; Piezoelectric System; Shoulder and Elbow. , a Johnson & Johnson company, is a leading global provider of orthopaedic devices for hip, knee, extremities and trauma, as well as bone cement and operating room products. Examine your inventory immediately to determine if you have the subject lot and quarantine theproduct. g. DePuy Knee Replacement Complications. 325 Paramount Dr Raynham MA 02767-5199: For Additional Information Contact: 508-828-3769: Manufacturer Reason for Recall: Cement mixer used to prepare cement for surgery may not Smartset ghv was used to cement an attune total knee using the smartset cemvac vacuum mixing system. Depth-dose profiles were simulated using four phantom geometries: Catalog NOs. Product Classification Orthopedic Devices Device Class 2 This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis. Depuy considers the investigation closed. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. 3 Methods and materials for containment and clearing up Clean up small spills of less than20 ml through use of absorbent material and dispose of contaminated material as hazardous waste. 07. com. ATTUNE KNEE SYSTEM TIBIAL BASE AFFIXIUM FIXED BEARING SIZE 6: Arthroplasty: 3/29/24: K202194 ; K213781 ; K232303 Implants have a central cavity that allows them to be packed Acrylic bone cement is the most common method of fixation for primary total knee arthroplasty (TKA). Also useful in stabilisation of vertebral fractures/luxations. If the bone cement chips or the cement’s bond breaks with the bone, the aseptic loosening can result in a host of problems. There are many brands that manufacture bone cement that has unfortunately been linked to failure or sometimes BCIS. Based in Warsaw, Indiana, the company Class 2 Device Recall DePuy CEMENT RESTRICTOR, Size 5: Date Initiated by Firm: January 27, 2011: Date Posted: March 17, 2011: Recall Status 1: Terminated 3 on April 23, 2013: Recall Number: Z-1690-2011: Sterile, DePuy Orthopaedics. Investigation summary: no device associated with this report was received for examination. Type of Device: BONE CEMENT : BONE CEMENT. On (b)(6) 2020 patient underwent a left knee revision due to pain and discomfort. DePuy CMW 1 Bone Cement; DePuy SmartSet HV Bone Cement; Stryker/Howmedia Simplex HV Bone Cement Download scientific diagram | Composition of DePuy Ibérica CMW 1 bone cement radio-opaque. Product Classification Orthopedic Devices Device Class 2 Implanted device? This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis Manufacturer Depuy Orthopaedics, Inc. They come in a variety of sizes (length and diameter) Recall History devices via the 510( k) pathway with bone cement as the method of fixation. Cm2 cement was used. 20 Other in vitro studies have demonstrated that cement applied to the tibia and the keel increases pull-out strength DEPUY ORTHOPAEDICS INC US DEPUY CMW 2 20G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 3322-020: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Unspecified Infection (1930); Swelling/ Edema (4577) Event Date 02/10/2022: Event Type Injury Event Description Search As part of Johnson & Johnson, DePuy continues to innovate. . No complications were noted. Frank filed his lawsuit in October 2018 against DePuy, Johnson & Johnson, Stryker Corporation, Howmedica, and Aap Implants Inc. The patella was resurfaced and cement mfg is depuy. Clip Appliers. penetrate the surgical site, and remain inside the patient without the surgeon’s awareness. Please refer to Table K863528 DEPUY BICONDYLAR TOE PROSTHESIS DEPUY, INC. The long clinical heritage of our DePuy CMW™ bone cement product range has allowed us to evaluate and refine the product range over time. SMARTMIX™ Bone Cement Mixing Systems; SMARTSET™ Bone Cement and DePuy CMW™ Bone Cement; Power Tools. It Was Anticipated That AShorter Pressurization Time Would ReduceThe Risk Of Movement Whilst Waiting ForThe Cement To Set. DePuy CMW-1 Bone Cement Problems. 016S Vertecem V+ Cement Kit Material(s) Containers for storage, transport and use: Container No. Patella baja was noted and was corrected Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 ENDURANCE BONE CEMENT 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3070040: Device Problems Fluid/Blood Leak (1250); Device Damaged Prior to Use (2284) The long clinical heritage of our DePuy CMW™ bone cement product range has allowed us to evaluate and refine the product range over time. There was no surgical delay. Its companies form part of the Johnson & Johnson Medical Devices Group. It may also be intended for use as a filler in the case of bone pathologies (e. 19 In vitro studies have shown that applying cement to both the under-surface of the tibial tray and onto the tibial bone leads to optimal cement penetration. Contact your DePuy Synthes Sales Consultant to coordinate the return of any affected devices or callcustomer service following the typical returns process in DEPUY CMW 9619821 DEPUY CMW 1 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 3312-040: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Search Alerts/Recalls : New Search | Submit an Adverse Event Report: Brand Name: DEPUY CMW 1 40G. 3 Failure for the cement-implant interface may be due to the poor Orthopaedic cement, non-antimicrobial A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. Should additional information be It was noted that the reservoir was filled with dried cement. BONE CEMENT: Back to Search Results: Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002) cases such as mine with a total knee replacement. Cement was mixed as per proper technique, the cement had been housed in the theatre for preceding 3-4 hours and theatre temperature was 18. 700 Orthopaedic Dr Warsaw IN 46582-3994: For Additional Information Contact: DePuy Synthes Sales Consultant. 3 The manufacturer has initiated the recall and not all Device Recall DePuy CEMENT RESTRICTOR , Size 1. 2293230 Product Subject to this Removal: Part Number Part Description Lot GTIN 1504-01-204 ATTUNE CR Femoral Right Size 4 Porous 3883327 10603295041474 Dear Surgeon, By letter of 11Aug2023 (Attachment 1), DePuy Ireland has initiated a medical device recall (removal) of one lot of the Device Recall DePuy CEMENT RESTRICTOR, Size 5 Model / Serial Product Code 546018000, Lot ET5EW4, Size 5. CMW1 is a medium/high viscosity cement for Class 3 Device Recall SIMPLEX Bone Cement with Tobramycin: Date Initiated by Firm: November 07, 2022: Date Posted: December 20, 2022: Recall Status 1: Open 3, Classified: Recall Number: Z-0737-2023: Recall Event ID: 91147: 510(K)Number: K014199 : Product Classification: Bone cement - Product Code LOD: Product: Tobra Full Dose CE Antibiotic Class 2 Device Recall DEPUY ASR RESURFACING FEMORAL HEADS: Date Initiated by Firm: August 23, 2010: Date Posted: March 24, 2011: Recall Status 1: Terminated 3 on August 29, 2013: Recall Number: Z-1769-2011: Recall Event ID: 57177: 510(K)Number: K032659 : The femoral resurfacing heads have a polished exterior surface and an internal cavity DePuy has admitted that "knee implants are known to fail at the cement-bone interface or at the cement-implant interface. Manufacturer Depuy Orthopaedics, Inc. Drillable Bone Void Filler is a calcium phosphate cement with collagen for use in bone fracture repair procedures. Previous Cases. 4 The confidence 11cc spinal cement system was not returned for evaluation. DePuy ASR Hip Recall; DePuy Attune Knee Replacements; Depuy Curved Condylar Plate; DePuy Hips; DePuy Orthopaedics Hip Replacements; DePuy Synthes SimartSet GHV Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. " Improperly mixing the cement can lead to the artificial knee device failing to adhere to the bone and also can cause infections. For information on compatibility with other devices or systems, consultation with a DePuy Synthes representative is recommended. 040S TRAUMACEM V+ Bone Cement, injectable Description TRAUMACEM V+ Injectable Bone Cement consists of sterile packed compo - nents to create radiopaque TRAUMACEM V+ Injectable Bone Cement. The procedure was completed without complications. CMW3 is a more fluid cement which is more appropriate Orthopaedic bone cement restrictor instrumentation. One such brand is DePuy, a subsidiary of the Johnson & Johnson pharmaceutical empire. 1 degrees c. 3 packs (120g) cement were opened during the surgery, and one of which had been partially deformed. 2 (Liquids, SmartSet) Date: 8 May 2014 Supersedes: May 2011 Page 4 of 9 6. Military Veteran Advocacy. The cases, which allege that the metal-on-metal hip Class 2 Device Recall DEPUY ASR RESURFACING FEMORAL HEADS: Date Initiated by Firm: August 23, 2010: Date Posted: March 24, 2011: Recall Status 1: Terminated 3 on August 29, 2013: Recall Number: Z-1768-2011: Recall Event ID: 57177: 510(K)Number: K032659 : The femoral resurfacing heads have a polished exterior surface and an internal cavity Orthopaedic cement, antimicrobial A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic prosthetic implants to the living bone and/or to fill voids in the case of bone pathologies, and to treat infected joint prostheses or osteomyelitis; it may also be used prophylactically in primary or uninfected revision total joint Little is known about patients with bone cement hypersenstivity after total knee arthroplasty (TKA). of units Material(s) Medical Device Product Recall (Removal) – Ref. The surgeons said they “encountered a high rate of debonding of tibial implant-cement interface,” with 21 complaints in the last two months alone. The DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy Orthopaedics. 15,16 ISO 5833:2002 Minimum Standard: 70 MPa ISO 5833:2002 Minimum Standard: 50 MPa Graph 6 Graph 7 DePuy CMW 1 DePuy CMW 1 DePuy CMW 2 DePuy CMW 3 Gentamicin DePuy They found that all 15 patients had loose components in the knee — and no bone cement bonding the tibial baseplate to the bone. DePuy Synthes Lot No: MFG Lot No: 254400520 ABC22844 C22844 ABC22845 C22845 ABC34279 C34279 ABC34280 C34280 ABC4107 C4107 ABC4108 C4108 ABC4112 C4112 Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY IRELAND - 9616671 ENDURANCE BONE CEMENT 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3070040: Device Problem Adverse Event Without Identified Device or Use Problem On (b)(6) 2014 patient received a left attune total knee to treat oa. Any DePuy SmartSeal pressurisers that have a For more than 60 years PALACOS ® has been successfully used in arthroplasty for effective and permanent fixation of implants in bone. Investigation summary : no device associated with this report was received for examination. 5mm Variable Angle Bone cement is an epoxy used to attach the components of a knee implant to human bone during a total knee replacement (TKR). jnj. SmartsetBone Cements Are The Latest Cements In The Depuy Synthes Portfolio. , to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). Main Street Suite 200 Pensacola, FL 32502 (844) 794-7402 (850) 202-1010. Type of Device: BONE It was reported that a part of the secondary packaging polyethylene bag containing powder of the cement (p/n: (b)(4)) had already been distorted when it was opened for using during the tka surgery on (b)(6) 2019. 1818910 DEPUY/CMW 2G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 545032500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Unspecified Infection (1930); No Code Available (3191) Event Date 01/23/2019: Event Type Injury Manufacturer Narrative Search DEPUY BONE CEMENT: Back to Search Results: Model Number 3102-040: Device Problem Insufficient Information (3190) Search Alerts/Recalls : New Search | Submit an Adverse Event Report: Brand Name: BONE CEMENT. Notifications were sent to consignees with the Device Classification Name: Bone Cement, Antibiotic: 510(k) Number: K061144: Device Name: DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT: Applicant JOHNSON & JOHNSON/ JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD. This would prevent the reservoir from being loaded correctly and a new set would Class 2 Device Recall DePuy Spine: Date Initiated by Firm: March 22, 2011: Date Posted: April 27, 2011: Recall Status 1: Terminated 3 on February 20, 2013: Recall Number: Z-2102-2011: Recall Event ID: 58271: Product Classification: They are used to place bone cement percutaneously at a desired location. Aseptic loosening is when the device moves out of place without The DePuy CMW bone cement exceeds all the requirements for set and polymerized bone cement in the international standard for Acrylic Bone cements (ISO 5833:2002). 2. Type of Device: BONE CEMENT : Patient was revised to address loosening of the tibial component at the cement to implant and bone to cement interface. However, by May of the same year, she began complaining of extreme pain down her right knee DePuy Orthopaedics, Inc. Any DePuy SmartSeal pressurisers that have a To characterise the dosimetric impact of the presence of the DePuy CMW 1 bone cement, percentage depth-dose profiles (PDDs) were simulated using the BEAMnrc/DOSXYZnrc Monte Carlo (MC) user codes for EGSnrc , , for a 6 MV 10 × 10 cm 2 field produced using a validated Varian iX Clinac model , . Dor: (b)(6) 2023. This device is intended to restrict bone cement migration into the distal medullary canal during implantation Cementing technique has been shown to be important for long-term implant survival. DePuy CMW 1 Bone Cement (NOT CMW 2 or CMW 3) Simplex HV Bone Cement (Stryker/Howmedica) SmartSet HV Bone Cement (DePuy) Defective Bone Cement. D Device Description: SmartSet GHV Gentamicin Bone Cement is a self-curing cement, to which one gram of (023012) and its similarity in indications for use to DePuy 1 Gentamicin Loosening can result in bone fractures, instability, and catastrophic falls. The tibia was removed without difficulty. Medium Viscosity Antibiotic Bone Cement, Sterile. 5 bar according to the manufacturing process specification, mps-hpc006 rev u. The system consists of five parts: o Femoral Head The FDA’s database shows at least six other DePuy knee replacement recalls since 2013. The SynJect Cement Delivery System is intended for the application of DePuy Synthes PMMA-based bone cement, Vertecem V+ Cement Kit, with the intent to augment cancellous bone. DePuy Ireland is initiating a medical device recall (removal) of one lot of the ATTUNE™ Cementless CR Femurs listed in the above table. The Attune Knee lawsuits being filed against DePuy Synthes claim the medical device was defectively designed so that surgical glue would not properly hold the device to the patient’s tibia bone. It Was Developed To Have A ShorterSetting Time And Thus Increase EfficiencyOf Surgery. The pumped maxed at 179. DePuy Knee Implant Recall. DEPUY IRELAND - 9616671 DEPUY CMW 2 20G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 3322-020: Device Problem Loss of or Failure to Bond (1068) Patient Problem Insufficient Information (4580) Event Date 03/13/2023: Event Type Injury Event Description The patient was revised due to tibial tray collapsed medially. 1 Early attempts to use acrylic cement in orthopaedic surgery may have failed due to a misunderstanding around how the cement functions. Affected side: left knee. Between 2003 and 2013, DePuy issued at least 200 knee replacement-related recalls. Among the brands This item may require 1-2 days to ship out from our facility. 7/3. 5mm Midfoot Fusion Bolt for osteotomies and other large bone Depuy International Heraeus Kulzer Stryker-Howmedica-Osteonics Zimmer Inc. Femur, tibia & insert along with depuy bone cement were removed. Several studies have described good short-term outcomes; however, there have been reports of early failures due to tibial baseplate debonding at the implant-cement interface of The ATTUNE Knee System (DePuy Synthes, West Chester, PA). 0 Introduction The survivorship of Total Knee Replacement (TKR) is at the cement-bone interface may appear as radiolucent lines and is usually attributed to poor penetration of the cement into the bone. Frank was subject to the use of Stryker bone cement known as Simplex HV bone cement—the HV standing for high viscosity—on Nov. Class 2 Device Recall DePuy CEMENT RESTRICTOR, Size 4: Date Initiated by Firm: January 27, 2011: Date Posted: March 17, 2011: Recall Status 1: Terminated 3 on April 23, 2013: Recall Number: Z-1687-2011: Sterile, DePuy Orthopaedics. (sticker sheet page 276 of 570). , many of them Authorized Wholesale Dealer of Bone Cement - DePuy CMW Heritage Bone Cements, Stryker Surgical Simplex P Bone Cement, Antibiotic Bone Cement and Biocompsites Stimulan Rapid Cure offered by Divine Surgical, Chandigarh. Lot numbers below should be inspected and swapped out if the bushing is incorrectly assembled: Part No. 1988: 5 Pro Osteon ® Implant 500 Hydroxyapatite Bone Void Filler: P860005: Interpore Intl. The femoral Orthopaedic cement, non-antimicrobial A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. Refer to the corresponding instruction for use regarding indications, contraindications, compatibility, use, precautions, warnings and side effects of the The DePuy CMW 1 Bone Cement is a high viscosity medium-setting time bone cement relative to other DePuy Synthes PMMA cements. About the database; How to use the database; Download the data; FAQ; Credits; Events. 3, 5 Used by Sir John Charnley, who pioneered modern joint replacement, CMW 1 Bone Cement DePuy bone cement recalled; InspireMD raising $13. Examine your inventory The bone cement has no intrinsic adhesive properties but relies instead on close mechanical interlock between the irregular bone surface and the prosthesis. It is intended for treatment of osteoporotic fractures of the upper and lower extremities in combination with DePuy Synthes fixation devices intended for Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY IRELAND - 3015516266 DEPUY CMW 1 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3312040: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Class 2 Device Recall DePuy: Date Initiated by Firm: June 29, 2022: Create Date: July 20, 2022: Recall Status 1: Open 3, Classified: Recall Number: Z-1419-2022: Recall Event ID: 90557: Template - Product Code HWT: Product: ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral Bone Cement (4) Cages and Spacers (11) Cartilage Restoration. DePuy Orthopaedics, Inc. There were no indicated intra-operative complications. 5 minutes at 65 degrees f, depuy orthopaedics cMW DePuy Spine, Inc. There was loosening at the bone/cement interface. Model / Serial Product Code 546010000, Lot ET5DV4, Size 1. sent an Urgent Information - Recall Notice dated February 6, 2015, to all affected consignees for a voluntary recall of one lot of SMARTSET¿ GHV Gentamicin Bone Cement because the affected cement is partially agglomerated (clumped together). depuy orthopaedics’ fast-set cements can help surgical teams maximize efficiency and potentially reduce oR time. Water was however found slowly leaking behind the Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of 2 DePuy Synthes fiGuidance for Cementing Primary TKR Cementing Total Knee Replacements 1. Product complaint # (b)(4). The ATTUNE™ Cementless Total Knee System is intended for cementless use within the ATTUNE™ Total Knee Replacement System. the intended use stated in the ifu for the smartset¿ gmv endurance DePuy (a subsidiary of Johnson & Johnson): 477 recalls (4 class I; 470 class II; 3 class II). Manufacturer (Section D) DEPUY: MDR Report Key: 4603943: MDR Text Key: 5695722: Report Number: ComparedTo Other Depuy Synthes Bone Cements,Depuy Cmw 2 Bone Cement ProvidesRapid Working Time For Efficient Surgery. 3027: Applicant: DEPUY, INC. Manufacturer Narrative The defendants include Depuy Synthes Sales Inc. 17 E. All demonstrated hypersensitivity to bone cement via skin patch and/or lymphocyte transformation testing. Depuy cement manufacturer was used. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral DEPUY ORTHOPAEDICS INC US SMARTSET HV BONE CEMENT 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number underwent a primary right knee arthroplasty to treat severe arthritis. The smartset¿ gmv endurance gentamicin bone cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the us fda. Four quantities of depuy cements were used. Also find Bone Cement price list | ID: 20011537791 Product complaint # (b)(4). Bone Cement (3) Cages and Spacers (10) Instruments (2) Personalization and Planning (1) Plates and Screws (4) Power Tools Small Bones (2) Retractors (2) A 6. I discovered that there were knee replacements that had been on recall, etc. Product Description : Antibiotic Simplex Bone Cement with Erythromycin/Colistin is packaged in two sterile components. While using the cement, it appeared to go off (hard) quicker than expected (at approx. Almost all significant problems necessitate revision surgery. 702. sent an Urgent Information - Recall Notice dated February 6, 2015, to all affected consignees for a voluntary recall of one lot of SMARTSET GHV Gentamicin Bone SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or DePuy CMW™ 2 Bone Cement is our fast-setting high viscosity bone cement, setting in approximately 6. SMARTSET Bone Cements are the latest cements in the DePuy Synthes portfolio. The ATTUNE S+™ Technology is yet another way that DePuy Synthes is driving evidence-based innovation intended to make continuous enhancements with the goal of positively affecting patient outcomes and Product Information: SmartSet HV Bone Cement, 40G, High-Viscosity Manufacturer Part # 3092-040 Description Developed to meet the needs of today's orthopedic surgeons Medium viscosity for a less doughy consistency HPIS Code 550_17_0_0 Latex Free Yes UNSPSC 42. FDA Recalls of DePuy Knee Replacement System | 4/27/2018; DePuy Knee Replacement Systems and At 19°C (66°F) DePuy CMW3 bone cement sets approximately after 12 ½ minutes. CMW is the industry standard. Brands Associated with Bone Cement Failure. One component is an ampoule containing 10ml, or 20ml of a colourless, flammable liquid monomer that has a sweet slightly acrid odour and contains Methyl methacrylate (monomer), N,N-dimethyl pare toluidine and Hydroquinone. , Johnson & Johnson, Stryker Corporation, Howmedica Osteonics Corporation, and AAP Implants Inc. Doi: (b)(6) 2021. When an implant loosens without concurrent infection, the result is known as aseptic loosening. Recalled models include the LCS Knee Implant-Meniscal bearing insert (2008, mislabeling); the LCS Duofix Femoral Component (an Device: DEPUY 1 BONE CEMENT: Generic Name: BONE CEMENT: Regulation Number: 888. 1992: 1 Collagraft Bone Graft The Long ClinicalHeritage Of Our Depuy Cmw™ Bone Cement Product Range Has AllowedUs To Evaluate And Refine The Product Range Over Time. The FDA described the product as "A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. WARSAW, IN 46581-0988: PMA Number TRAUMACEM™ V+ System is a polymethylmethacrylate cement for augmentation of a trauma device that allows injection of a controlled amount of cement into a femoral head. We present 7 patients implanted with 8 TKAs with clinical failure and a cement hypersensitivity diagnosis. DePuy SmartSeal™ pressuriser: femoral and acetabular pressurisers (5 pack) for use with orthopaedic bone cement. All 7 patients also showed hypersensitivity to metal, most commonly Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 SMARTSET HV BONE CEMENT 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 3092-040: Device Problem Adverse Event Without Identified Device or Use Problem Device Recalls Device Safety Communications GUDID Advanced Search; Search Help; Home; About; News; API; Download; Help; View More DEPUY (IRELAND) Primary DI Number: 10603295174295 Issuing Device Description: Smartset GMV HIGH PERFORMANCE GENTAMICIN Medium Viscosity Bone Cement 40g CLOSE. A new tibia (stemmed) with augments was re-implanted. Unfortunately, these high viscosity bone cements The Urgent recall notice described the recalled product, explained the reason for the recall, and directed consignees to cease further distribution, complete the attached Reconciliation form and quarantine and return all affected products through the DePuy Orthopaedics Sales consultant, Fax 1-787-287-7681 or Email to vbaez1@its. News & Press. Wash the area with detergents and water, Bone Cement: 510(k) Number: K033563: Device Name: SMARTSET GHV GENTAMICIN BONE CEMENT: Applicant: DEPUY ORTHOPAEDICS, INC. Circular Staplers. It provides a reliable working time for modern cementing techniques with a setting time of approximately 12. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral DePuy CMW Bone Cement Designed for total hip replacement. all lot numbers are affected by this recall. 2 Cement achieves a mechanical bond to the bone by DePuy CMW Bone Cement Designed for total hip replacement. Over 700,000 knee replacement surgeries are performed each year in the U. 4 Clinical Results DePuy CMW 1/DePuy CMW 1 Gentamicin: More Than 40 Years of Clinical Experience DePuy CMW 1 bone cement has the longest clinical heritage of any orthopaedic bone cement. Free Shipping on Purchases Over $100 | Use Code TAKE5 for 5% OFF DePuy SmartSet Bone Bone Cement. Product Information: SmartSet MV Bone Cement, 40GManufacturer Part # 3122040Description Developed to meet the needs of today's orthopedic surgeons Medium viscosity for a less doughy consistency HPIS Code 550_17_0_0 Latex Free Yes UNSPSC 42296702 DePuy SmartSet Bone Cement - Bone cement Palacos ® R Bone Cement: P810020: Smith & Nephew Richard, Inc. , hip replacement, Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 DEPUY CMW 1G 40G BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3315040: Device Problems Component Missing (2306); Incomplete or Missing Packaging (2312); Missing At least four product liability lawsuits have been filed in the wake of Johnson & Johnson’s DePuy ASR hip recall that was announced last week. Indications that DePuy CMW-1 bone cement may have failed to remain attached to the bone The patient was revised due to tibial tray collapsed medially. 15,16 ISO 5833:2002 Minimum Standard: 70 MPa ISO 5833:2002 Minimum Standard: 50 MPa Graph 6 Graph 7 DePuy CMW 1 DePuy CMW 1 DePuy CMW 2 DePuy CMW 3 Gentamicin DePuy The resin was consequently left for 24 h to solidify completely. The pump was tested with a pressure gage to ensure output of the correct pressure. Founded in 1895 by chemist and pharmaceutical salesman Revra DePuy, DePuy was the world's first orthopaedics company. Bone cement: A mixture formed by the chemical reaction of two chemical agents (a monomer and a polymer) that produces a grout-like material that is used for some joint The DePuy Ceramax® Ceramic Total Hip System is a ceramic-on-ceramic bearing total hip replacement prosthesis system. The patient¿s knee also felt unstable and weak. Cobalt HV Bone Cement (Biomet/DJO Surgical) DePuy CMW 1 Bone Cement; Simplex HV Bone Cement (Stryker/Howmedica) SmartSet HV Bone Cement (DePuy) Bone cement failure typically occurs for one of two reasons: either aseptic loosening or bone cement implantation syndrome. Available In Medium And High Viscosity Formulations, With And WithoutGentamicin, Smartset Bone Cements Were Developed To Meet TheNeeds Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 ENDURANCE BONE CEMENT 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3070040: Device Problems Fluid/Blood Leak (1250); Device Damaged Prior to Use (2284) D G Enterprise - Offering Depuy Smartset Gentamicin Bone Cement, Model Name/Number: 3092-040 at ₹ 2600/piece in Ahmedabad, Gujarat. 3 Failure for the cement-implant interface may be due to the poor Class 2 Device Recall DePuy Spine: Date Initiated by Firm: March 22, 2011: Date Posted: April 27, 2011: Recall Status 1: Terminated 3 on February 20, 2013: Recall Number: Z-2103-2011: Recall Event ID: 58271: Product Classification: They are used to place bone cement percutaneously at a desired location. Device Recall DePuy Cement, bone, vertebroplasty - Product Code NDN: Product: The firm, DePuy Synthes, sent an "URGENT FIELD SAFETY NOTIFICATION-RECALL CONFIDENCE KIT SPINAL CEMENT SYSTEM" dated 12/2017 to its consignees. The number of complaints received for this failure mode will continue to be monitored and product updates/ recommendations will be implemented at the post market surveillance review dependent upon 2 DePuy Synthes SMARTSET ™ Bone Cements Product Information INTRODUCTION Our experience in PMMA bone cements is extensive. Clinically the knee didn¿t look infected. Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 DEPUY CMW 1G 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3315040: Device Problems Component Missing (2306); Incomplete or Missing Packaging (2312); Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 ENDURANCE BONE CEMENT 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3070040: Device Problem Device Damaged Prior to Use (2284) Patient Problem No Clinical Class 2 Device Recall DePuy CEMENT RESTRICTOR , Size 1: Date Initiated by Firm: January 27, 2011: Date Posted: March 17, 2011: Recall Status 1: Terminated 3 on April 23, 2013: Recall Number: Z-1686-2011: Recall Event ID Sterile, DePuy Orthopaedics. The other side of the tibia was clean. What MRI Patient was revised due to arthrofibrosis. , Depuy Orthopaedics Inc. Type of Device: CEMENT. The plaintiff says he was was Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 SMARTSET HV BONE CEMENT 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3092040: Device Problem Adverse Event Without Identified Device or Use Problem The DePuy CMW bone cement exceeds all the requirements for set and polymerized bone cement in the international standard for Acrylic Bone cements (ISO 5833:2002). Clips. We examined Loosening of the device due to cement failure; Bone fractures; Unexpected wear and tear; DePuy has also faced recalls and warnings for other surgical and joint replacement devices including surgical tools and hip replacements. 4-5 minute mark. after allegedly suffering complications following his knee replacement surgery in 2015. About Recall Status 1: Terminated 3: Recall Number: Z-0064-2014: Recall Event ID: 66248: SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures where infection by gentamicin A DePuy Sigma knee replacement system was used during her surgery, which was affixed using DePuy Cement. 5 minutes at 19°C 4. 1984: 6 DePuy 1 Bone Cement: P960001: DePuy Orthopaedics Inc. Porous coated implants may be used with or without cement. The femoral component, tibial component and tray were removed and attune revision was put in. DePuy Knee Implant-Related Recalls These instruments were meant to help surgeons position the Stryker Triathlon knee implant DEPUY ORTHOPAEDICS, INC. Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. The FDA began investigating DePuy CMW 1 bone cement after receiving an Adverse Event Report in September 2012. Bone cement products that have been linked to failure are: DePuy CMW 1 Bone Cement, DePuy SmartSet HV Bone Cement, Stryker/Howmedia Simplex HV Bone Cement, and Biomet/DJO Surgical Cobalt HV Bone Cement. However, based on the complaint what most likely happened was that the surgeon connected the cap to the reservoir before transferring cement, which would cause the plunger to be in the empty cement reservoir. 3 bar before the safety valve engaged. Search Alerts/Recalls : New Search | Submit an Adverse Event Report: Brand Name: DEPUY CMW 2 20G. 5 minutes at 19°C (66°F). This can lead to oxygen deficiency, embolism, heart attacks and in some cases, death. DEPUY CMW - 9610921 SMARTSET GHV GENTAMICIN 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 5450-35-500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) including depuy patella were utilized along with depuy cement x2. Manufacturer DePuy By letter of 11Aug2023 (Attachment 1), DePuy Ireland has initiated a medical device recall (removal) of one lot of the ATTUNETM Cementless CR Femurs listed in the above table. According to one report, a number of orthopedic surgeons have Letter states reason for recall, health risk and action to take: Please take the Following Steps: 1. Article number Article name 07. In a clinical setting, cemented hip stems are fixed in position with bone cement with approximate density and Young's modulus of 1. The notification described the product, problem and actions to be taken. S. DePuy CMW 2 is designed for digital application to small joints such as the knee patella and the hip DePuy Synthes issued Urgent Medical Device Correction Letter on June 29 2022. In June 2015, DePuy issued a Class II recall for approximately 3,274 units of Product complaint # (b)(4). Letter states reason for recall, health risk and action to take: 1. That’s more than any other knee implant manufacturer. DePuy Synthes is a franchise of orthopaedic and neurosurgery companies acquired by Johnson & Johnson in 1998. 5-188. The plaintiff points out that the defendant originally received FDA clearance for their product through the FDA’s 510(k) notification process, which means that the defendants did not have to go through the comprehensive The complaint acknowledges contributions from the several medical journals that indicate that HV bone cements including the DePuy bone cement known as SmartSet HV are causing components of otherwise well-reviewed knee prosthetics to become loose or even disassociate from the bone. Device Characteristics. Affected side: right knee. The FDA Recalls Depuy's LPS Diaphyseal Sleeve | 4/13/2018; DePuy Knee Replacement DEPUY CMW - 9610921 DEPUY/CMW 2G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 5450-32-500: Device Problem Loss of or Failure to Bond (1068) Patient Problem Insufficient Information (4580) Search Alerts/Recalls : New Search | Submit an Adverse Event Report: Brand Name: DEPUY/CMW 2G. I ask the doctor office staff to request a copy of Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. 574-267-8143: Manufacturer Reason 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. With a setting time of 6. Its proven clinical use has been demonstrated by more than 40 million procedures worldwide. 8M; The company first issued recall letters in early February due to partial agglomeration of one lot that could require surgeries to be delayed. Center for Leadership. On (b)(6) Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 DEPUY CMW 3 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 3332-040: Device Problem Adverse Event Without Identified Device or Use Problem (2993) DePuy CMW 1 Bone Cement; Stryker/Howmedia Simplex HV Bone Cement; DePuy SmartSet HV Bone Cement; Biomet/DJO Surgical Cobalt HV Bone Cement; How to Recover Compensation for Bone Cement: Mass Tort. Acrylic bone cements for vertebroplasty Bone Cements: Formulation, Modification, and Characterization 1055 Cementing Total Knee Replacements 1. Various options are available. 16, 2015. 700 ORTHOPAEDIC DR. Class 2 Device Recall DePuy P. DePuy developed and markets products under the Codman, DePuy Mitek, DePuy Orthopaedics, and DePuy Spine brands. || SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric Wholesaler of Bone Cement - Depuy Smartset HV Bone Cement, Depuy CMW 1 Bone Cement, Palacos R Bone Cement and Surgical Simplex P offered by Y K Surgicals, New Delhi, Delhi. from publication: Influence of HRGO Nanoplatelets on Behaviour and Processing of PMMA Bone Cement for The AAOS Device Recall Dashboard provides orthopaedic surgeons with timely recall information that will protect the health and well-being of their patients. Investigation summary: no information received with this individual complaint indicated that a broader investigation or corrective action was necessary. CMW1 is a medium/high viscosity cement for digital application CMW2 is a rapid set cement suitable for the acetabular cup via digital application. Should additional information be Class 2 Device Recall DePuy CEMENT RESTRICTOR, Size 3: Date Initiated by Firm: January 27, 2011: Date Posted: March 17, 2011: Recall Status 1: Terminated 3 on April 23, 2013: Recall Number: Z-1689-2011: Sterile, DePuy Orthopaedics. Manufacturer: DePuy Spine, Inc. 700 ORTHOPAEDIC DRIVE: Recalls: CDRH Recalls - - and transfer of bone cement into a suitable application or delivery system. This is within the specification of 151. 1 Among Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY ORTHOPAEDICS INC US DEPUY CMW 2G 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3325040: Device Problem Chemical Problem (2893) Patient Problem Insufficient Information 2 DePuy Synthes fiGuidance for Cementing Primary TKR Cementing Total Knee Replacements 1. As knee replacement has become a much more common solution to knee problems in younger patients, those (particularly those with pre-existing heart problems) may face an increased risk developing bone cement implantation syndrome. cifhvvj gwqmjt qpwsxbo srzbr lwxs qulmmjkh hiqzobg gvr kjem aygci