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

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00889024211889), received between Aug 28, 2019 and Sep 22, 2026 — classified as 7 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50856858 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY LEGAL A PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, A LEGAL CLAIM HAS BEEN MADE DUE TO PAIN AND LIMITED MOBILITY. IT WAS NOTED THAT THE SURGEON REPORTED LOOSENING VIA X-RAY. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Loss of Range of Motion; Pain

  MAUDE report 23547183 ↗
• InjuryOct 30, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY FIVE YEARS POST IMPLANTATION DUE TO PAIN AND MALPOSITION OF THE DEVICE. THE PATIENT REQUIRED A RIGHT KNEE REPLACEMENT DUE TO OSTEOARTHRITIS. SUBSEQUENTLY, SHE EXPERIENCED PAIN IN HER RIGHT KNEE AND BOOKED AN APPOINTMENT WHEREUPON SHE UNDERWENT FURTHER TESTS. SHE WAS INFORMED THAT THE KNEE HAD ROTATED AND THAT IT NEEDED TO BE REVISED. THE PATIENT UNDERWENT REVISION SURGERY ON AN UNKNOWN DATE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 23426955 ↗
• InjuryOct 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information

  MAUDE report 23220431 ↗
• InjurySep 2, 2025Degraded; Degraded

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS EXPERIENCING POST-OP PAIN, SWELLING, AND INSTABILITY AND WAS HAVING A GENERAL DIFFICULTY AMBULATING PRIOR TO THE REVISION SURGERY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Arthritis; Hyperextension; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 22940101 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA PROCEDURE FIVE MONTHS POST IMPLANTATION DUE TO RANGE OF MOTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Loss of Range of Motion

  MAUDE report 21761078 ↗
• InjuryOct 1, 2024Naturally Worn; Naturally Worn

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

  Patient problems: Failure of Implant; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20344384 ↗
• MalfunctionMar 28, 2023Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16633129 ↗
• MalfunctionNov 29, 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 12883273 ↗
• MalfunctionNov 18, 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 12837089 ↗
• MalfunctionMay 3, 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 11760124 ↗
• MalfunctionApr 1, 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 11601786 ↗
• MalfunctionAug 14, 2020Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10407564 ↗
• MalfunctionSep 17, 2019Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9075518 ↗
• MalfunctionAug 28, 2019Difficult to Insert; Difficult to Insert

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8939031 ↗

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-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-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-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.