NexGen® Legacy® 5964-16-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024001138), received between Sep 21, 2021 and Dec 30, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

21 other recalls cover devices cleared under the same FDA submission (K173057, K991581, P060037); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2024Adverse 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: Impaired Healing

  MAUDE report 21034472 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL BILATERAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 6 YEARS POST-OP, THE PATIENT STATED HIS LEFT KNEE HAS FAILED AND WAS EXPERIENCING PAIN AND DIFFICULTY WEIGHT-BEARING. UPON MEDICAL EVALUATION, REVISION HAS BEEN RECOMMENDED BUT HAS NOT BEEN SCHEDULED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 19561120 ↗
• InjuryJan 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information

  MAUDE report 18610052 ↗
• InjuryDec 28, 2023Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY DUE TO A WORK RELATED INJURY RESULTING IN BILATERAL KNEE POSTTRAUMATIC ARTHRITIS. SINCE THE INITIAL PROCEDURE, THE PATIENT HAS COMPLAINT OF ONGOING AND INCREASING PAIN, SWELLING, INSTABILITY, LIMP, AND HEAT IN THE JOINT. THE PATIENT HAS BEEN RECOMMENDED FOR REVISION SURGERY AS RECENT X-RAYS SUGGEST LOOSENING. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 7 YEARS POST-OP DUE TO ASEPTIC LOOSENING. DURING THE REVISION, THE SURGEON NOTED OSTEOLYSIS TO THE TIBIA AND FEMUR, A LARGE DEFECT SECONDARY TO CHRONIC LOOSENING, AND FIBROUS MEMBRANE FORMATION. THE TIBIA, FEMUR, AND ARTICULATING SURFACE WERE EXCHANGED WITH COMPETITOR PRODUCTS WITHOUT COMPLICATIONS. THE PATELLA REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Burning Sensation; Failure of Implant; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis; Tissue Breakdown

  MAUDE report 18409385 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE PROCEDURE. THE PATIENT SUFFERED FROM A TENDON RUPTURE APPROXIMATELY 2 MONTHS POST PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA 3 MONTHS POST TENDON RUPTURE DUE TO STIFFNESS. ATTEMPTS TO GATHER MORE INFORMATION ARE UNDERWAY, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Muscular Rigidity

  MAUDE report 13252640 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT SUFFERED FROM A TENDON RUPTURE APPROXIMATELY 2 MONTHS POST PROCEDURE. ATTEMPTS TO GATHER MORE INFORMATION ARE UNDERWAY, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 13252252 ↗
• InjurySep 21, 2021Adverse 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: Pain

  MAUDE report 12505326 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173057, K991581, P060037. 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-0324-2020 · Oct 10, 2019 · Terminated
  LPS-MOB ART SURF IMPL D 9MM
• 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-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-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-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-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-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-1038-2018 · Nov 29, 2017 · Terminated
  LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L This device is indicated for patients with severe knee pain and disability
• Z-0663-2018 · Jul 24, 2017 · Terminated
  NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
• Z-0841-2016 · Jan 11, 2016 · Terminated
  NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes "" This device i
• 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

…and 6 more.