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

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889024211896), received between Sep 5, 2019 and Aug 12, 2025 — classified as 4 injuries, 6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 3 YEARS POST IMPLANTATION OF AN INITIAL LEFT KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A REVISION DUE TO STIFFNESS, PAIN, AND REDUCED RANGE OF MOTION IN THE KNEE. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 22783311 ↗
• InjuryMar 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 18894110 ↗
• InjuryJan 10, 2023Material Erosion; Material Erosion

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Arthralgia; Failure of Implant; Inadequate Pain Relief; Pain; Scar Tissue; Synovitis

  MAUDE report 16132752 ↗
• MalfunctionMay 4, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO INSERT THE ARTICULAR SURFACE OVER THE TIBIAL PLATE. AFTER TRYING FOR 10 MINUTE AND HAVING NO SUCCESS, HE OPENED A NEW ARTICULAR SURFACE WAS OPENED AND IMPLANTED. THERE WAS A 10 MINUTE DELAY. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14272832 ↗
• InjuryApr 20, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, SWELLING, INSTABILITY AND THE KNEE WAS HOT TO THE TOUCH FOLLOWING KNEE ARTHROPLASTY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Alteration in Body Temperature; Pain; Swelling/ Edema

  MAUDE report 14163483 ↗
• MalfunctionDec 30, 2021Difficult to Insert; Difficult to Insert

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13118739 ↗
• MalfunctionNov 2, 2021Difficult 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 12737464 ↗
• MalfunctionAug 19, 2021Difficult 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 12343716 ↗
• MalfunctionAug 19, 2021Difficult 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 12342125 ↗
• MalfunctionSep 5, 2019Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

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

  Patient problems: No Information

  MAUDE report 8965232 ↗

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-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-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.