NexGen® 5986-37-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00889024218833), received between Jun 28, 2021 and Sep 22, 2026 — classified as 30 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (22 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Insufficient Device Problem Information

  It was reported that the patient is experiencing unknown complications approximately nine (9) years following left knee arthroplasty.No additional information is available.

  Patient problems: Insufficient Information

  MAUDE report 50856787 ↗
• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  It was reported patient underwent a revision procedure approximately 6 years post implantation due to unknown reasons. Attempts to obtain additional information have been made; however, no more is available.

  Patient problems: Insufficient Information

  MAUDE report 50236866 ↗
• InjuryAug 13, 2026Loosening of Implant Not Related to Bone-Ingrowth

  It was reported patient is experiencing loosening approximately five years post implantation. No further information is available.

  Patient problems: Aseptic loosening

  MAUDE report 50234445 ↗
• InjuryFeb 16, 2026Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Aseptic loosening; Pain

  MAUDE report 24345118 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY NINE YEARS FOUR MONTHS POST IMPLANTATION DUE TO PAIN. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 24208925 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: Arthrofibrosis; Unspecified Infection

  MAUDE report 23840666 ↗
• InjuryDec 17, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Aseptic loosening; Pain

  MAUDE report 23827397 ↗
• InjuryDec 10, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: Aseptic loosening; Pain; Swelling/ Edema

  MAUDE report 23769517 ↗
• InjuryMay 12, 2025Osseointegration Problem; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Osseointegration Problem; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED BY PATIENTS' LEGAL COUNSEL THAT THE PATIENT UNDERWENT A KNEE REVISION PROCEDURE DUE TO UNKNOWN REASONS APPROXIMATELY 8 YEARS 5 MONTHS POST IMPLANTATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Insufficient Information; Joint Laxity; Joint effusion; Loss of Range of Motion; Pain; Synovitis

  MAUDE report 22001859 ↗
• InjuryJan 27, 2025Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY SIX YEARS AND THREE MONTHS POST IMPLANTATION DUE TO FEMORAL AND TIBIAL COMPONENT LOOSENING. DURING THE REVISION BOTH THE TIBIA AND FEMORAL IMPLANTS WERE FOUND LOOSE, TIBIA IMPLANT HAD SUNK MEDIALLY, AND OSTEOLYSIS WAS NOTED AROUND THE FEMORAL COMPONENT. THERE IS NO ADDITIONAL INFORMATION.

  Patient problems: Extraskeletal ossification; Failure of Implant; Loss of Range of Motion; Osteolysis; Pain; Radiolucent Lines

  MAUDE report 21244992 ↗
• InjuryOct 30, 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: Aseptic loosening; Pain

  MAUDE report 20568374 ↗
• InjuryOct 10, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS TIBIAL COMPONENT LOOSENING AND PAIN APPROXIMATELY THREE (3) YEARS AND THREE (3) MONTHS POST-OPERATIVELY. INITIAL AND REVISION OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 20418423 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED DEEP VEIN THROMBOSIS FOUR (4) DAYS FOLLOWING AN INITIAL RIGHT KNEE ARTHROPLASTY. THE PATIENT WAS PLACED ON ANTICOAGULANTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20071056 ↗
• InjuryAug 26, 2024Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN, SWELLING AND AMBULATION DIFFICULTIES SECONDARY TO LOOSENING AND MIGRATION OF THE TIBIAL COMPONENT APPROXIMATELY FIVE (5) YEARS POST-OPERATIVELY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Failure of Implant; Fall; Pain; Swelling/ Edema

  MAUDE report 20068219 ↗
• InjuryJul 22, 2024Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY THREE YEARS EIGHT AND A HALF MONTHS POST IMPLANTATION DUE TO FEMORAL AND TIBIAL IMPLANT LOOSENING. DURING THE REVISION THE TIBIAL COMPONENT WAS NOTED TO BE LOOSE WITH NO CEMENT ATTACHED TO BASEPLATE AND OSTEOLYTIC TISSUE WAS REMOVED. THE FEMORAL COMPONENT WAS WELL FIXED. REVISION WAS COMPLETED WITHOUT COMPLICATIONS. RIGHT KNEE ASPIRATION WAS PERFORMED, AND THE REPORTED RESULTS INDICATED NO INFECTION.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Failure of Implant; Joint effusion; Osteolysis; Pain; Radiolucent Lines; Swelling/ Edema

  MAUDE report 19794109 ↗
• InjuryMay 1, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Pain

  MAUDE report 19224473 ↗
• InjuryApr 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information

  MAUDE report 19124206 ↗
• InjuryMar 26, 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: Ambulation or Postural Difficulties; Aseptic loosening; Failure of Implant; Implant Pain; Insufficient Information; Osteolysis; Pain

  MAUDE report 18981810 ↗
• InjuryMar 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED PATIENT IS EXPERIENCING UNKNOWN ISSUE POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18937216 ↗
• InjuryMar 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  UPON RECEIPT OF ADDITIONAL INFORMATION, THIS DEVICE WAS DETERMINED TO BE NOT REPORTABLE. CORRESPONDENCE INDICATED THAT THE TIBIAL COMPONENT REMAINED WELL FIXED AND DID NOT EXHIBIT LOOSENING THAT LED TO REVISION SURGERY OF THE PATIENT. THE PREVIOUSLY REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 18891074 ↗
• InjuryMar 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT WAS REVISED ONE MONTH POST IMPLANTATION FOR KNEE PAIN AND THE TIBIAL IMPLANT WAS FOUND TO BE GROSSLY LOOSE W/NO CEMENT ADHERED TO TITANIUM SURFACE. TIBIAL REVISED FOR LOOSENING. ALL OTHER IMPLANTS EXCEPT THE PATELLA WERE REVISED AS A BEST PRACTICE. PATELLA WAS NOT REVISED. NOTE- THERE WERE 2 ARTICULAR SURFACES LISTED IN THE ORIGINAL NOTES. HOWEVER, IT IS UNKNOWN WHICH WAS USED, SO BOTH ARE LISTED IN H10.

  Patient problems: Pain

  MAUDE report 18879291 ↗
• InjuryMar 7, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY 6.5 YEARS POST IMPLANTATION DUE TO PAIN AND LOOSENING. THE TIBIAL IMPLANT WAS FOUND TO BE GROSSLY LOOSE WITH NO CEMENT ADHERED TO THE TITANIUM SURFACE. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 18862601 ↗
• InjuryFeb 5, 2024Naturally Worn; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FIVE YEARS POST IMPLANTATION DUE TO UNKNOWN REASON. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Cyst(s); Failure of Implant; Insufficient Information; Osteolysis; Pain; Radiolucent Lines; Swelling/ Edema; Synovitis

  MAUDE report 18639321 ↗
• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS UNKNOWN COMPLICATIONS APPROXIMATELY SIX (6) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18625995 ↗
• MalfunctionOct 19, 2023Loosening 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. APPROXIMATELY THREE YEARS LATER, THE PATIENT IS EXPERIENCING TIBIAL LOOSENING. NO REVISION HAS BEEN REPORTED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 17967627 ↗

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-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-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-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-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-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.