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

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00889024215153), received between Jan 25, 2021 and Mar 16, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Insufficient Device Problem Information

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

  Patient problems: Insufficient Information

  MAUDE report 24608628 ↗
• InjuryNov 6, 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

  MAUDE report 23488094 ↗
• InjuryAug 27, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS POST IMPLANTATION OF A PRIMARY LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT DEVELOPED PAIN, AND UNDERWENT A REVISION DUE TO ASEPTIC LOOSENING AND AVASCULAR NECROSIS OF THE PATELLA. THE PATELLA COMPONENT WAS REVISED AND ALL OTHER COMPONENTS WERE RETAINED.

  Patient problems: Aseptic loosening; Necrosis; Pain

  MAUDE report 22902063 ↗
• InjuryAug 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 4 YEARS POST IMPLANTATION OF A RIGHT PRIMARY TOTAL KNEE ARTHROPLASTY, THE PATIENT DEVELOPED PAIN AND UNDERWENT A REVISION DUE TO ASEPTIC LOOSENING OF THE PATELLA COMPONENT. FIBROSIS TISSUE WAS REMOVED AND PATELLA WAS REVISED; ALL OTHER COMPONENTS WERE RETAINED. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Fibrosis; Pain

  MAUDE report 22895221 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS THAT A PATIENT UNDERWENT A REVISION TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, SIX (6) YEARS AND FOUR (4) MONTHS POST-IMPLANTATION, THE PATIENT BEGAN EXPERIENCING SWELLING, PAIN, STIFFNESS, INSTABILITY, BUCKLING, REDNESS, DIFFICULTY WALKING, AND A CRACKING SOUND/LOUD PAINFUL POPS. DIAGNOSTIC IMAGING WAS PERFORMED AND DID NOT REVEAL LOOSENING OF THE CEMENTED COMPONENTS. ALL IMPLANTS REMAIN IMPLANTED AND ADDITIONAL MEDICAL INTERVENTION HAS NOT BEEN REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Erythema; Pain; Swelling/ Edema

  MAUDE report 21632154 ↗
• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT IS REPORTING PAIN, SWELLING, AMBULATION DIFFICULTIES, AND DECREASED RANGE OF MOTION. NO REVISION PROCEDURE HAS BEEN REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 19793152 ↗
• InjuryJul 12, 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: Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema

  MAUDE report 17311384 ↗
• InjuryJul 12, 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: Pain; Swelling/ Edema

  MAUDE report 17310426 ↗
• InjuryApr 17, 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: Adhesion(s); Ambulation or Postural Difficulties; Hemorrhage/Blood Loss/Bleeding; Joint effusion; Loss of Range of Motion; Pain; Synovitis

  MAUDE report 16751153 ↗
• InjuryMay 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT HAD SEVERAL FALLS WITH QUADRICEPS TENDON RUPTURE. APPROXIMATELY 2 MONTHS POST PROCEDURE THE TENDON WAS REPAIRED WITHOUT COMPLICATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 14270359 ↗
• InjurySep 22, 2021Adverse 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: Loss of Range of Motion; Scar Tissue

  MAUDE report 12515525 ↗
• InjuryJul 9, 2021Unsealed Device Packaging; Unsealed Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12144386 ↗
• InjuryFeb 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS STILL EXPERIENCING PAIN APPROXIMATELY TWO YEARS AND TWO MONTHS¿ POST IMPLANTATION. THE PATIENT RECEIVED A STEROID INJECTION FOR PAIN APPROXIMATELY SIX MONTHS AFTER THE INITIAL SURGERY. THE PATIENT REPORTED ONLY MINOR PAIN RELIEF AFTER THE INJECTION. THE PATIENT'S PAIN IS ONGOING AFTER THE TWO YEAR FOLLOW UP BUT TOLERATED WITHOUT FURTHER INTERVENTION. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Pain

  MAUDE report 11267303 ↗
• InjuryJan 25, 2021Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Pain; Swelling

  MAUDE report 11222342 ↗

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-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-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-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-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-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-2115-2017 · Apr 28, 2017 · Terminated
  NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
• 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-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-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.