NexGen® 5988-10-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024220942), received between Sep 29, 2022 and Feb 5, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

95 other recalls cover devices cleared under the same FDA submission (K173057, K872379, K933785); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 24268020 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant; Septic loosening

  MAUDE report 20903150 ↗
• InjuryNov 18, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING PERFORATED STEM ON FEMORAL SIDE FOUR YEARS POST IMPLANTATION. THE STEM PENETRATED THROUGH THE BONE CAUSING THE BONE TO FRACTURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

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

  MAUDE report 20708749 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A KNEE PROCEDURE. APPROXIMATELY 1 YEAR POST-OP, THE PATIENT WAS REVISED DUE TO PAIN AND STIFFNESS. THE TIBIAL COMPONENT, POLY, AND STEM WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 19995998 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT REPORTS PAIN, DECREASED MOBILITY, INSTABILITY, AND CANNOT WALK WITHOUT ASSISTANCE. NO REVISION PROCEDURE HAS BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 15502996 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173057, K872379, K933785. 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-0469-2023 · Dec 6, 2022 · Open, Classified
  NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02
• Z-0466-2023 · Dec 6, 2022 · Open, Classified
  NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
• Z-0467-2023 · Dec 6, 2022 · Open, Classified
  NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02
• Z-0468-2023 · Dec 6, 2022 · Open, Classified
  NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01
• Z-0471-2023 · Dec 6, 2022 · Open, Classified
  NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02
• Z-0470-2023 · Dec 6, 2022 · Open, Classified
  NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01
• 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-1039-2018 · Nov 29, 2017 · Terminated
  LPS PRECOAT SRF HDN FEM SZ D-L LPS PRECOAT SRF HDN FEM SZ D-R LPS PRECOAT SRF HDN FEM SZ E-L LPS POROUS SRF HDN FEM SZ D-LT LPS POROUS SRF HDN FEM SZ E-LT This device is indicated
• 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-1042-2018 · Nov 29, 2017 · Terminated
  CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE D/R CR OPTION FEM COMP SIZE E/L CR OPTION FEM COMP SIZE E/R CR OPTION FE
• Z-1041-2018 · Nov 29, 2017 · Terminated
  CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR PRECOAT FEM COMP SIZE E/R CR PRECOAT FEM COMP SIZE F/R CR PRECOAT FEM COMP SIZE G/L CR PRE
• 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-2115-2017 · Apr 28, 2017 · Terminated
  NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
• Z-1159-2016 · Jan 11, 2016 · Terminated
  Product 61 consists of all product under product code: JWH and same usage: Item no: 598003712 STD PRECOAT TIBIA PLATE S for use in total knee arthroplasty

…and 80 more.