NexGen® Legacy® 5964-22-10 (REF 00-5964-022-10)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024211704), received between May 17, 2021 and Dec 22, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING ONGOING PAIN AND INSTABILITY WITH BONE RESORPTION SINCE RECEIVING A RIGHT KNEE ARTHROPLASTY THREE (3) YEARS PRIOR. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23863142 ↗
• MalfunctionAug 19, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, ON AN UNKNOWN TIMEFRAME POST-IMPLANTATION, THE PATIENT BEGAN EXPERIENCING SYMPTOMS AND PRESENTED AT THE CLINIC WHERE RADIOLOGICAL EXAMINATION REVEALED OSTEOLYSIS. THE PATIENT IS CURRENTLY UNDERGOING FURTHER EXAMINATION. A REVISION OF THE KNEE JOINT MAY BE NECESSARY. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Osteolysis

  MAUDE report 22841608 ↗
• InjuryDec 22, 2021Noise, Audible; Patient Device Interaction Problem; Noise, Audible; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY THREE MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO PAIN, SWELLING, DIFFICULTY AMBULATING AND LIMITED RANGE OF MOTION. IN SPITE OF THE INTERVENTION, THE PATIENT CONTINUED TO EXPERIENCE THE SAME AND INCREASED SYMPTOMS. ADDITIONALLY, THE PATIENT EXPERIENCED CONTINUOUS WARMTH AND REDNESS TO THE SITE WHICH WAS RESISTANT TO ICE, ELEVATION, AND ANTIBIOTIC THERAPY. ALL CULTURES AND BLOODWORK WERE NEGATIVE FOR INFECTION. APPROXIMATELY ONE YEAR AND NINE MONTHS POST INITIAL IMPLANTATION, THE PATIENT WAS REVISED OF ALL COMPONENTS WITH IMPLANTATION OF AN ANTIBIOTIC SPACER WITH INTRA-OP FROZEN SECTION SPECIMENS CONCERNING FOR INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Impaired Healing; Inflammation; Loss of Range of Motion; Muscular Rigidity; Pain; Scar Tissue; Subclinical Infection; Swelling/ Edema; Synovitis

  MAUDE report 13061375 ↗
• InjuryMay 17, 2021Naturally Worn; Naturally Worn

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 11836232 ↗

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-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-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-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.