NexGen® Legacy® 5994-30-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024635692), received between Oct 16, 2023 and Jul 24, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN INITIAL KNEE SURGERY, THE TIBIAL COMPONENT WOULD NOT ASSEMBLE WITH THE POLY. AN ADDITIONAL POLY WAS TESTED, HOWEVER, THE TIBIAL COMPONENT WOULD STILL NOT ASSEMBLE. THERE WAS A SURGICAL DELAY OF AN UNKNOWN TIME AMOUNT DUE TO THE SURGEON TEMPORARILY CLOSING WHILE THE SALES REP PICKED UP ANOTHER POLY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822221 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY. NO OBVIOUS CAUSE FOR INSTABILITY WAS IDENTIFIED DURING THE REVISION PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 17943587 ↗

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-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-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-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-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-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-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-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-0535-2011 · Sep 15, 2010 · Terminated
  Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size E Left, sterile, REF 00-5764-015-51.
• Z-0531-2011 · Sep 15, 2010 · Terminated
  Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size F Right, sterile, REF 00-5996-016-02.

…and 8 more.