NexGen® 5972-65-35 (REF 00-5972-065-35)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00889024635395), received between Mar 31, 2022 and Nov 10, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

85 other recalls cover devices cleared under the same FDA submission (K173057, K933785); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Aseptic loosening

  MAUDE report 23509218 ↗
• InjurySep 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 23168851 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS UNKNOWN REASONS APPROXIMATELY FOUR (4) YEARS AND EIGHT (8) MONTHS POST-OPERATIVELY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21366040 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Impaired Healing

  MAUDE report 21034480 ↗
• InjurySep 10, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY WHICH WAS SUBSEQUENTLY REVISED ABOUT FIVE YEARS POST IMPLANTATION DUE TO LOOSENING AND A TIBIAL PERIPROSTHETIC FRACTURE SUSTAINED AFTER A TRIP AND FALL. THE INITIAL POLY PATELLA REMAINED INTACT, AND ALL OTHER COMPONENTS WERE EXCHANGED FOR COMPETITOR PRODUCT. DURING THE POSTOP HOSPITAL STAY, THE PATIENT CONTINUED TO EXPERIENCE WOUND HEALING ISSUES AND DRAINAGE ATTRIBUTED TO THE ANTICOAGULANT THERAPY. ABOUT TWO MONTHS POST REVISION THE PATIENT RETURNED TO SURGERY FOR AN INCISION AND DRAINAGE WASHOUT WITH NO PRODUCT EXCHANGE PER SURGEON DISCRETION. STAPH AUREUS AND E. FAECALIS WERE ISOLATED FROM THE CULTURES TAKEN INTRAOPERATIVE. AS OF THE LAST CLINIC VISIT RECORDS PROVIDED SHOW THE PATIENT HAS BEEN OFF ANTIBIOTICS WITH NO SIGN OF INFECTION. IT HAS NOW BEEN REPORTED THE PATIENT UNDERWENT THE FIRST OF A 2-STAGE REVISION APPROXIMATELY ONE YEAR, ONE MONTH AFTER THE LAST OFFICE VISIT. DURING THE REVISION, SIGNIFICANT SYNOVITIS WITH PATELLAR OSTEOLYSIS WAS NOTED. ALL IMPLANTS WERE REMOVED, AND AN ANTIBIOTIC NAIL WAS PLACED WITHOUT COMPLICATION. A GASTROC FLAP WITH SPLIT THICKNESS SKIN GRAFTING WAS PERFORMED AFTER EX

  Patient problems: Bacterial Infection; Failure of Implant; Impaired Healing; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 20180815 ↗
• InjuryAug 20, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Fall; Muscle/Tendon Damage

  MAUDE report 20002258 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD A TOTAL KNEE REVISION 4 YEARS POST IMPLANTATION DUE TO INFECTION. AN ADDITIONAL REVISION OF THE PATELLAR COMPONENT TOOK PLACE APPROXIMATELY 18 MONTHS POST PROCEDURE DUE TO ASEPTIC LOOSENING. SUBSEQUENTLY, THE PATIENT REPORTED AN ONSET OF ANTERIOR KNEE PAIN THAT BEGAN 8 MONTHS AFTER THE PATELLA REVISION.

  Patient problems: Ambulation or Postural Difficulties; Joint Contracture; Pain

  MAUDE report 19661244 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19560983 ↗
• InjuryApr 24, 2024Malposition of Device; Naturally Worn; Noise, Audible; Malposition of Device; Naturally Worn; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 3.5 YEARS LATER, THEY UNDERWENT A REVISION OF THE PATELLA FOR NOISE, MALALIGNMENT, AND SCAR TISSUE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain; Scar Tissue

  MAUDE report 19172895 ↗
• InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Fall; Hyperextension; Pain; Swelling/ Edema

  MAUDE report 18890651 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Impaired Healing

  MAUDE report 17136121 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN AND SUSPECTED ASEPTIC LOOSENING APPROXIMATELY THREE (3) YEARS POST-OPERATIVELY. HOWEVER, DURING THE REVISION, ALL IMPLANTS WERE FOUND TO BE WELL-FIXED. ALL DEVICES WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Osteopenia/ Osteoporosis; Pain

  MAUDE report 13970736 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN AND SUSPECTED ASEPTIC LOOSENING APPROXIMATELY THREE (3) YEARS POST-OPERATIVELY. HOWEVER, DURING THE REVISION, ALL IMPLANTS WERE FOUND TO BE WELL-FIXED. ALL DEVICES WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Osteopenia/ Osteoporosis; Pain

  MAUDE report 13970697 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173057, K933785. One submission often covers many models, so check the product and lot details in each record.

• Z-2092-2023 · May 19, 2023 · Terminated
  NexGen Precoat Stemmed Tibial Plate Size 5
• Z-0321-2020 · Oct 10, 2019 · Terminated
  Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800
• Z-1040-2018 · Nov 29, 2017 · Terminated
  LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT This device is indicated for patients with severe knee pain and disability
• Z-1039-2018 · Nov 29, 2017 · Terminated
  LPS PRECOAT SRF HDN FEM SZ D-L LPS PRECOAT SRF HDN FEM SZ D-R LPS PRECOAT SRF HDN FEM SZ E-L LPS POROUS SRF HDN FEM SZ D-LT LPS POROUS SRF HDN FEM SZ E-LT This device is indicated
• Z-1041-2018 · Nov 29, 2017 · Terminated
  CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR PRECOAT FEM COMP SIZE E/R CR PRECOAT FEM COMP SIZE F/R CR PRECOAT FEM COMP SIZE G/L CR PRE
• Z-1042-2018 · Nov 29, 2017 · Terminated
  CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE D/R CR OPTION FEM COMP SIZE E/L CR OPTION FEM COMP SIZE E/R CR OPTION FE
• Z-1038-2018 · Nov 29, 2017 · Terminated
  LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L This device is indicated for patients with severe knee pain and disability
• Z-2115-2017 · Apr 28, 2017 · Terminated
  NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
• Z-0835-2016 · Jan 11, 2016 · Terminated
  NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Porous Fem NexGen Knee LPS Precoat Fem prosthesis, knee, patellofemorotibial, semi-co
• Z-1159-2016 · Jan 11, 2016 · Terminated
  Product 61 consists of all product under product code: JWH and same usage: Item no: 598003712 STD PRECOAT TIBIA PLATE S for use in total knee arthroplasty
• Z-1147-2016 · Jan 11, 2016 · Terminated
  Product 49 consists of all product under product code: JWH and same usage: Item no: 597206529 NEXGEN ALL-POLY PATELLA, 597206532 NEXGEN ALL-POLY PATELLA, 597206535 NEXGEN ALL-POL
• Z-1151-2016 · Jan 11, 2016 · Terminated
  Product 53 consists of all product under: product code: JWH and same usage: Item no: 597002501 NEXGEN PRECOAT PEG TIB PL 597002502 NEXGEN PRECOAT PEG TIB PL 597003501 NEXGEN PR
• Z-0590-2016 · Dec 3, 2015 · Terminated
  NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3. Tibial component of im
• Z-0449-2016 · Dec 2, 2015 · Terminated
  Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patie
• Z-2552-2014 · Jul 22, 2014 · Terminated
  Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD

…and 70 more.