NexGen® Legacy® 5994-15-91Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024224803), received between Feb 9, 2022 and Mar 13, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

23 other recalls cover devices cleared under the same FDA submission (K173057, K960279); 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.

• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAS CONTINUING PAIN, SWELLING, SYNOVITIS AND DIFFICULTY AMBULATING SIX YEARS, SEVEN MONTHS POST IMPLANTATION. AN ARTHROSCOPIC PROCEDURE WAS COMPLETED SIX YEARS POST IMPLANTATION HOWEVER SYMPTOMS PERSISTED. NO ADDITIONAL INFORMATION PROVIDED BY PATIENT AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21597653 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY FORTY-SIX MONTHS POST-IMPLANTATION DUE TO LIMITED FLEXION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Loss of Range of Motion

  MAUDE report 20878674 ↗
• InjuryMay 13, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE PROCEDURE ON AN UNKNOWN DATE TO RECEIVE A NON-ZB KNEE IMPLANT. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION APPROXIMATELY FIVE (5) YEARS AGO WHERE THEY RECEIVED ZB IMPLANTS. THE PATIENT LATER UNDERWENT ANOTHER REVISION APPROXIMATELY FIVE (5) POST-IMPLANTATION OF ZB IMPLANTS DUE TO FEMORAL FRACTURE AND SUBSEQUENT LOOSENING. ALL IMPLANTS WERE REMOVED AND REVISED TO AN RHK. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 19304037 ↗
• InjuryFeb 9, 2022Adverse 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: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 13497559 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173057, K960279. One submission often covers many models, so check the product and lot details in each record.

• Z-1039-2025 · Jan 6, 2025 · Open, Classified
  NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
• Z-1038-2025 · Jan 6, 2025 · Open, Classified
  NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
• 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-1036-2018 · Nov 29, 2017 · Terminated
  LPS FEM COMP SZ B-L LPS FEM COMP SZ B-R LPS FEM COMP SZ C-L LPS FEM COMP SZ C-R LPS FEM COMP SZ D-L LPS FEM COMP SZ D-R LPS FEM COMP SZ E-L LPS FEM COMP SZ E-R LPS FEM COMP SZ F-L
• Z-1037-2018 · Nov 29, 2017 · Terminated
  LCCK FEM IMPLANT SZ C-L LCCK FEM IMPLANT SZ C-R LCCK FEM IMPLANT SZ D-R LCCK FEM IMPLANT SZ E-L LCCK FEM IMPLANT SZ E-R LCCK FEM IMPLANT SZ F-L LCCK FEM IMPLANT SZ F-R This device
• Z-1035-2018 · Nov 29, 2017 · Terminated
  LPS OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L LPS OPTION FEMORAL D-R LPS OPTION FEMORAL E-L LPS OPTION FEMORAL E-R LPS OPTION FEMORAL F-L LPS OPTION FEMORAL
• Z-1040-2018 · Nov 29, 2017 · Terminated
  LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT This device is indicated for patients with severe knee pain and disability
• Z-1034-2018 · Nov 29, 2017 · Terminated
  LPS FEM IMPLANT SZ H-R This device is indicated for patients with severe knee pain and disability
• Z-0834-2016 · Jan 11, 2016 · Terminated
  NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Pr
• Z-1146-2016 · Jan 11, 2016 · Terminated
  Product 48 consists of all product under product code: JWH and same usage: Item no: 597206526 NEXGEN ALL-POLY PATELLA, for use in total knee arthroplasty
• Z-1575-2015 · Apr 2, 2015 · Terminated
  NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur.
• 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-0531-2011 · Sep 15, 2010 · Terminated
  Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size F Right, sterile, REF 00-5996-016-02.
• Z-0533-2011 · Sep 15, 2010 · Terminated
  Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size G Left, sterile, REF 00-5764-017-51.

…and 8 more.