NexGen® Legacy® 5964-40-10 (REF 00-5964-040-10)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00889024634992), received between Sep 16, 2022 and Jan 6, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974073 ↗
• MalfunctionDec 15, 2025Positioning Failure; Positioning Failure

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23812586 ↗
• MalfunctionJun 17, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING SURGERY THE ARTICULAR SURFACE COULD NOT ASSEMBLE THE MATTING TIBIAL TRAY. THE SURGICAL TECHNIQUE WAS UTILIZED; THERE WAS A 5 MINS DELAY. NO HARM OCCURRED AND NO FOREIGN BODIES WERE RETAINED. A SECOND DEVICE WAS USED TO COMPLETE THE SURGERY. ATTEMPTS HAVE BEEN MADE, AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22242118 ↗
• MalfunctionMay 19, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INSERT WAS DEFECTIVE. THE SURGEON SAID THAT IT WAS PROBABLY DUE TO A BAD POSITIONED INSERT RESULTING IN ONE OF THE LOCKS BEING DAMAGED DURING THE BEATING. ANOTHER INSERT WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047534 ↗
• MalfunctionDec 9, 2024Difficult 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 20878639 ↗
• MalfunctionSep 18, 2024Difficult 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 20250285 ↗
• MalfunctionSep 5, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT WHILE THE SURGEON WAS ASSEMBLING THE ARTICULAR SURFACE WITH THE TIBIAL PLATE, THE ARTICULAR SURFACE COULD NOT BE SEATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ARTICULAR SURFACE AFTER A THIRTY (30) MINUTE DELAY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20145409 ↗
• MalfunctionJul 15, 2024Difficult 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 19745753 ↗
• MalfunctionSep 18, 2023Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764925 ↗
• MalfunctionJul 26, 2023Difficult to Insert; Difficult to Insert

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398981 ↗
• InjuryApr 5, 2023Detachment of Device or Device Component; Naturally Worn; Noise, Audible; Detachment of Device or Device Component; Naturally Worn; Noise, Audible

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TWO YEARS AND EIGHT MONTHS POST IMPLANTATION DUE TO DISASSOCIATION. THE ARTICULAR SURFACE DISASSOCIATED FROM TIBIAL BASEPLATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Metal Related Pathology; Swelling/ Edema

  MAUDE report 16681234 ↗
• MalfunctionSep 16, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE TIBIAL INSERT WOULD NOT SEAT IN THE TIBIAL TRAY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15438823 ↗

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-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-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.