NexGen® Legacy® 5964-32-12 (REF 00-5964-032-12)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024634930), received between Feb 24, 2022 and May 22, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Positioning Failure

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE ARTICULAR SURFACE WOULD NOT MATE PROPERLY WITH THE TIBIAL TRAY. A SECONDARY DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER COMPLICATION. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25255357 ↗
• InjurySep 27, 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: Insufficient Information

  MAUDE report 20320433 ↗
• InjuryAug 27, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE ARTHROPLASTY. APPROXIMATELY 5 YEARS POST-OP, THE PATIENT REPORTS EXPERIENCING PAIN, SWELLING, IMPLANT SHIFTING, AND WORN BONE AND IS AMBULATING WITH CRUTCHES. THE PATIENT IS SCHEDULED FOR A REVISION. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Erosion; Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 20078392 ↗
• MalfunctionAug 25, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE ARTICULAR SURFACE WOULD NOT MATE WITH THE TIBIAL TRAY. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES AFTER MULTIPLE ATTEMPTS AT IMPLANTATION HOWEVER THE SURGERY EVENTUALLY NEEDED TO BE COMPLETED WITH A SECOND DEVICE OF THE SAME SIZE. THERE WAS NO PATIENT IMPACT AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624124 ↗
• MalfunctionJun 24, 2022Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING A KNEE ARTHROPLASTY, THE TIBIAL INSERT WOULD NOT SEAT ON THE TIBIAL TRAY. ANOTHER TIBIAL INSERT WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14799833 ↗
• MalfunctionFeb 24, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A KNEE ARTHROPLASTY, THE TIBIAL INSERT WOULD NOT SEAT ON THE TIBIAL TRAY. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592304 ↗

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-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-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-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.