NexGen® 5988-10-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024220973), received between Oct 27, 2023 and Dec 26, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 23895878 ↗
• 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 23865508 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE THIRTY MONTHS POST IMPLANTATION DUE TO FEMORAL LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 21469170 ↗
• InjuryFeb 12, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT WAS REVISED BECAUSE THERE WAS METAL DEBRIS. THE FEMUR WAS NOT SECURE TO THE STEM EXTENSION IT WAS ATTACHED TO. THE HCP DEDUCED THE SCREWS USED TO SECURE THE STEM EXTENSION TO THE FEMUR LOOSENED, OR WERE DAMAGED. THE FEMORAL AND STEM WERE REVISED FOR CAUSE.

  Patient problems: Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 21364346 ↗
• 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 18021785 ↗

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-0466-2023 · Dec 6, 2022 · Open, Classified
  NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
• 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-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-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-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-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-1133-2016 · Jan 11, 2016 · Terminated
  Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use in total knee arthroplasty

…and 80 more.