NexGen® 5990-36-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889024224186), received between Feb 24, 2021 and Aug 5, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 reports).

24 other recalls cover devices cleared under the same FDA submission (K173057, K862632, K946150, 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient underwent a right total knee arthroplasty and was subsequently revised approximately 1 year and 6 months post-implantation due to instability and mechanical loosening. Subsequently, 3 months after the revision, the patient began experiencing pain, swelling, stiffness, fever in the knee, and limitations in normal activities following the procedure. The devices remain implanted. Attempts have been made and no further information has been provided.

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

  MAUDE report 50143795 ↗
• InjuryFeb 5, 2026Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Aseptic loosening

  MAUDE report 24268024 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity; Pain

  MAUDE report 23895877 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity; Pain

  MAUDE report 23895873 ↗
• InjuryMay 22, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT INITIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO RECURRING INFECTION. IT WAS NOTED THAT THE PATIENT APPEARED TO HAVE FEMORAL LOOSENING AND WOULD HAVE REQUIRED DISTAL FEMORAL REPLACEMENT BUT WAS UNAVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22071645 ↗
• InjuryMay 22, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT INITIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO RECURRING INFECTION. IT WAS NOTED THAT THE PATIENT APPEARED TO HAVE FEMORAL LOOSENING AND WOULD HAVE REQUIRED DISTAL FEMORAL REPLACEMENT BUT WAS UNAVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22071637 ↗
• InjuryJul 1, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REPLACEMENT APPROXIMATELY TWELVE MONTHS POST-IMPLANTATION DUE TO LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 19645304 ↗
• InjuryJul 1, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REPLACEMENT APPROXIMATELY TWELVE MONTHS POST-IMPLANTATION DUE TO LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 19645285 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE REPLACEMENT PERFORMED ON AN UNKNOWN DATE WITH UNKNOWN PRODUCT. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE LOOSENING AT THIS TIME ZIMMER BIOMET PRODUCT WAS IMPLANTED. APPROXIMATELY ONE YEAR, THREE MONTHS POST IMPLANTATION THE PATIENT HAD AN MRI THAT SHOWED A COLLECTION OF FLUID OVER THE MEDIAL ASPECT OF THE LEFT THE GASTROCNEMIUS MUSCLE SECONDARY TO A HEMATOMA. EDEMA WAS ALSO NOTED. THE PATIENT CONTINUED TO REPORT PAIN AND SWELLING. DIAGNOSTIC IMAGING COMPLETED ONE YEAR SIX MONTHS AFTER THE MRI SCAN SHOWED ¿EVIDENCE OF LOOSENING ABOUT THE CEMENT MANTLE OF THE TIBIAL COMPONENT¿. THE PATIENT HAS REPORTED SHE NOW HAS A LIFELONG INFECTION THAT HAS EATEN SOME OF THE BONE IN HER LEFT LEG AND IS REQUIRED STRONG ANTIBIOTICS FOR THE REST OF HER LIFE. PATIENT ALSO REPORTS ANTIBIOTICS HAVE IMPACTED HER RA CAUSING PERSISTENT PAIN AND DISCOMFORT AS WELL AS INSTABILITY AND NOW MUST USE A BRACE AND A CANE TO HELP SUPPORT HER GAIT. NO FURTHER DETAILS OR OUTCOMES HAVE BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Erosion; Hemothorax; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 18021856 ↗
• InjuryJun 29, 2023Adverse 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: Bacterial Infection; Erosion; Failure of Implant; Inflammation; Necrosis; Scar Tissue

  MAUDE report 17228860 ↗
• InjuryFeb 24, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A LEFT LEG AMPUTEE STOOD UP FROM HIS WHEEL CHAIR ON HIS RIGHT LEG, TWISTED AND FELL. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Fall

  MAUDE report 11373288 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173057, K862632, K946150, 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-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-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-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-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-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-0530-2011 · Sep 15, 2010 · Terminated
  Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size F Left, sterile, REF 00-5996-016-01.
• Z-0536-2011 · Sep 15, 2010 · Terminated
  Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size E Right, sterile, REF 00-5764-015-52.

…and 9 more.