NexGen® 5988-10-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024220959), received between Aug 20, 2021 and Apr 17, 2024 — classified as 1 injury, 1 malfunction.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2024Packaging Problem; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19125244 ↗
• InjuryAug 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY FOUR YEARS AND TEN MONTHS¿ POST IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 12348835 ↗

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-0467-2023 · Dec 6, 2022 · Open, Classified
  NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02
• Z-0470-2023 · Dec 6, 2022 · Open, Classified
  NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01
• Z-0469-2023 · Dec 6, 2022 · Open, Classified
  NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02
• Z-0471-2023 · Dec 6, 2022 · Open, Classified
  NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02
• Z-0466-2023 · Dec 6, 2022 · Open, Classified
  NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
• Z-0468-2023 · Dec 6, 2022 · Open, Classified
  NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01
• 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-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-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-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-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-2115-2017 · Apr 28, 2017 · Terminated
  NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
• Z-0835-2016 · Jan 11, 2016 · Terminated
  NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Porous Fem NexGen Knee LPS Precoat Fem prosthesis, knee, patellofemorotibial, semi-co

…and 80 more.