NexGen® Legacy® 5964-32-10 (REF 00-5964-032-10)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00889024634923), received between Mar 29, 2022 and Aug 6, 2026 — classified as 8 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (5 reports).

9 other recalls cover devices cleared under the same FDA submission (K173057, K991581); 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50155746 ↗
• MalfunctionApr 23, 2026Difficult to Insert

  IT WAS REPORTED THAT THE LINER CANNOT BE ASSEMBLED TO MATE WITH THE TIBIAL TRAY. THE SURGICAL TECHNIQUE WAS UTILIZED. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETE WITH A SECOND LINER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965467 ↗
• MalfunctionDec 15, 2025Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801752 ↗
• MalfunctionJun 11, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT THE ARTICULAR SURFACE IMPLANT COULD NOT BE SEATED ON THE TIBIAL TRAY. ANOTHER ARTICULAR SURFACE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22187491 ↗
• InjuryFeb 18, 2025Adverse 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; Pain; Swelling/ Edema

  MAUDE report 21403361 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS ALLEGING HARM CAUSED BY THE DEVICE APPROXIMATELY SEVEN (7) YEARS FOLLOWING KNEE ARTHROPLASTY; HOWEVER, THE NATURE OF THE HARM IS UNKNOWN AND NO MEDICAL INTERVENTION HAS BEEN REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21055067 ↗
• InjurySep 13, 2024Naturally Worn; Naturally Worn

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

  Patient problems: Failure of Implant; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 20213284 ↗
• InjuryMar 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED PATIENT IS EXPERIENCING UNKNOWN ISSUE POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18936250 ↗
• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS UNKNOWN COMPLICATIONS APPROXIMATELY SIX (6) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18626141 ↗
• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING UNKNOWN ISSUE POST IMPLANTATION. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18622881 ↗
• MalfunctionDec 13, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INITIAL KNEE SURGERY, THE LINER WOULD NOT LOCK INTO THE TIBIAL COMPONENT. AS A RESULT, THERE WAS A 10-MINUTE SURGICAL DELAY AND A NEW LINER WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18317233 ↗
• MalfunctionJun 22, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THERE WAS A SCRATCH ON THE LINER DURING THE SURGERY. THERE WAS NO HARM TO THE PATIENT. THERE WAS A 10 MINUTE DELAY TO OBTAIN AND OPEN A NEW LINER. THE SURGICAL TECHNIQUE WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17182094 ↗
• MalfunctionMay 24, 2023Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991757 ↗
• InjuryJan 18, 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 16195562 ↗
• MalfunctionMay 19, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE DEVICE WOULD NOT SEATMATING IMPLANT DURING SURGERY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14434371 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FOUR YEARS POST IMPLANTATION DUE TO PAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Pain

  MAUDE report 13939553 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173057, K991581. 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-1045-2018 · Nov 29, 2017 · Terminated
  NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT This device is indicated for patients with severe knee pain and disability
• Z-1043-2018 · Nov 29, 2017 · Terminated
  LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL D-L LPS-FLEX OPTION FEMORAL D-R LPS-FLEX OPTION FEMORAL E-L LPS-FLEX OPT
• Z-1044-2018 · Nov 29, 2017 · Terminated
  LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT FEMORAL D-L LPS-FLEX PRECOAT FEMORAL D-R LPS-FLEX PRECOAT FEMORAL E-L LPS-FL
• Z-1152-2016 · Jan 11, 2016 · Terminated
  Product 54 consists of all product under product code: JWH and same usage: Item no: 596009900 NEXGEN TAPER PLUG for use in total knee arthroplasty
• Z-0832-2016 · Jan 11, 2016 · Terminated
  NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Product Usage
• Z-1023-2014 · Oct 11, 2013 · Terminated
  MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE LIN MODULAR CUP 7MM OFFSET LI
• Z-0609-2011 · Apr 16, 2010 · Terminated
  NexGen Complete Knee Solution Stemmed tibial broach impactor, Catalog # 00-5977-011-00, Zimmer Inc., Warsaw, IN.