NexGen® 5988-20-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024221444), received between Nov 1, 2019 and Dec 22, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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.

• InjuryDec 22, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A KNEE REPLACEMENT REVISION APPROXIMATELY 19 YEARS POST IMPLANTATION DUE TO ASEPTIC LOOSENING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Aseptic loosening

  MAUDE report 23865514 ↗
• InjuryOct 30, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT WAS REVISED FOR FEMORAL LOOSENING TWO YEARS, THREE MONTHS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening

  MAUDE report 23423982 ↗
• InjuryJul 15, 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 KNEE ARTHROPLASTY REVISION TO ADDRESS FEMORAL LOOSENING AND MEDIAL TIBIAL TRAY FRACTURE WITH INSTABILITY APPROXIMATELY EIGHT (8) YEARS POST-OPERATIVELY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 22505703 ↗
• InjuryJun 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Unspecified Infection

  MAUDE report 11967797 ↗
• InjuryNov 1, 2019Loss of or Failure to Bond; Unstable; Loss of or Failure to Bond; Unstable

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE AND SUBSEQUENTLY THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FIXATION SCREW OF THE INLAY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain; Reaction

  MAUDE report 9266661 ↗

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-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-0468-2023 · Dec 6, 2022 · Open, Classified
  NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01
• Z-0466-2023 · Dec 6, 2022 · Open, Classified
  NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
• 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-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-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-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-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-1151-2016 · Jan 11, 2016 · Terminated
  Product 53 consists of all product under: product code: JWH and same usage: Item no: 597002501 NEXGEN PRECOAT PEG TIB PL 597002502 NEXGEN PRECOAT PEG TIB PL 597003501 NEXGEN PR

…and 80 more.