NexGen® 5986-37-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00889024218840), received between Dec 2, 2019 and Feb 19, 2026 — classified as 31 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (20 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.

• InjuryFeb 19, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED BY LEGAL A PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, A LEGAL CLAIM HAS BEEN MADE DUE TO PAIN AND LIMITED MOBILITY. IT WAS NOTED THAT THE SURGEON REPORTED LOOSENING VIA X-RAY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Loss of Range of Motion; Pain

  MAUDE report 24390484 ↗
• InjuryDec 22, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THROUGH LEGAL NOTIFICATION THAT APPROXIMATELY 4 YEARS POST IMPLANTATION OF A LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT UNDERWENT REVISION DUE TO TIBIAL LOOSENING, PRESENTING IN PAIN, SWELLING, HOT SKIN, AND STIFFNESS. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 23870883 ↗
• InjuryNov 24, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED BY LEGAL, THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAS DEVELOPED SWELLING AND LOOSENING. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Inadequate Osseointegration; Pain; Swelling/ Edema

  MAUDE report 23630521 ↗
• InjuryOct 30, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY FIVE YEARS POST IMPLANTATION DUE TO PAIN AND MALPOSITION OF THE DEVICE. THE PATIENT REQUIRED A RIGHT KNEE REPLACEMENT DUE TO OSTEOARTHRITIS. SUBSEQUENTLY, SHE EXPERIENCED PAIN IN HER RIGHT KNEE AND BOOKED AN APPOINTMENT WHEREUPON SHE UNDERWENT FURTHER TESTS. SHE WAS INFORMED THAT THE KNEE HAD ROTATED AND THAT IT NEEDED TO BE REVISED. THE PATIENT UNDERWENT REVISION SURGERY ON AN UNKNOWN DATE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 23426940 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 3 YEARS POST IMPLANTATION OF AN INITIAL LEFT KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A REVISION DUE TO STIFFNESS, PAIN, AND REDUCED RANGE OF MOTION IN THE KNEE. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 22783325 ↗
• InjuryMay 12, 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 22004824 ↗
• InjuryMar 12, 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; Failure of Implant; Pain

  MAUDE report 21588194 ↗
• InjuryFeb 18, 2025Adverse 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

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE THREE YEARS POST IMPLANTATION DUE TO PAIN AND SWELLING. DURING THE REVISION THE TIBIA AND FEMUR WERE BOTH NOTED TO BE LOOSE. THE PATELLA WAS WELL FIXED AND THEREFORE NOT REVISED. FEMUR, TIBIA, AND ARTICULAR SURFACE WERE REVISED. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21401324 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS ALLEGING HARM CAUSED BY THE DEVICE APPROXIMATELY SEVEN (7) YEARS FOLLOWING KNEE ARTHROPLASTY; HOWEVER THE NATURE OF THE HARM IS UNKNOWN AND NO MEDICAL INTERVENTION HAS BEEN REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21055006 ↗
• InjuryNov 25, 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

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN WITH AMBULATION, SWELLING AND TIBIAL COMPONENT LOOSENING. INITIAL OPERATIVE NOTES NOTE NO INTRAOPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES NOTED THAT THE FEMORAL AND PATELLAR COMPONENTS WERE FOUND TO BE WELL-FIXED. HOWEVER, WHILE PERFORMING THE SYNOVECTOMY, THE TIBIAL COMPONENT WAS FOUND TO BE GROSSLY LOOSE AT THE IMPLANT/CEMENT INTERFACE AND WAS EASILY REMOVED. ALL COMPONENTS WERE REVISED WITH THE EXCEPTION OF THE PATELLA AND NO INTRAOPERATIVE COMPLICATIONS WERE NOTED.

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

  MAUDE report 20770564 ↗
• InjuryOct 1, 2024Naturally Worn; Naturally Worn

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

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

  MAUDE report 20344385 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY AND APPROXIMATELY 4 YEARS POST-OP, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20320431 ↗
• InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 20211951 ↗
• InjuryAug 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE ARTHROPLASTY. APPROXIMATELY 5 YEARS POST-OP, THE PATIENT REPORTS EXPERIENCING PAIN, SWELLING, IMPLANT SHIFTING, AND WORN BONE AND IS AMBULATING WITH CRUTCHES. THE PATIENT IS SCHEDULED FOR A REVISION. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Erosion; Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 20078402 ↗
• InjuryAug 5, 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; Joint effusion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19911764 ↗
• InjuryJul 2, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE POST IMPLANTATION DUE TO ASEPTIC LOOSENING OF TIBIA. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 19655562 ↗
• InjuryJun 17, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAS A PENDING REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT.

  Patient problems: Failure of Implant; Joint effusion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19548301 ↗
• InjuryJun 17, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE SEVEN MONTHS POST IMPLANTATION DUE TO ASEPTIC LOOSENING OF TIBIA. DURING THE REVISION SEVERE POLYETHYLENE SYNOVITIS AND GROSSLY LOOSE AND SUBSIDED TIBIA WERE NOTED. FEMUR, TIBIA, AND ARTICULAR SURFACE WERE REVISED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Failure of Implant; Pain; Synovitis

  MAUDE report 19547427 ↗
• InjuryJun 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FOUR YEARS POST IMPLANTATION DUE TO PAIN, SWELLING, EFFUSION, LIMPING, RADIOLUCENCY, AND SUBSIDENCE. DURING THE REVISION NOTED SYNOVITIS, WEAR, TIBIA LOOSE, AND OSTEOLYSIS. THE FEMUR, TIBIA, AND ARTICULAR SURFACE WERE EXCHANGED WITHOUT COMPLICATIONS. THE PATELLA REMAINED IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Osteolysis; Pain; Radiolucent Lines; Swelling/ Edema; Synovitis

  MAUDE report 19520158 ↗
• InjuryMar 22, 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; Insufficient Information; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 18959470 ↗
• InjuryMar 13, 2024Fracture; Fracture

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 18894113 ↗
• InjuryFeb 7, 2024Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Aseptic loosening; Bursitis; Cyst(s); Failure of Implant; Implant Pain; Insufficient Information; Joint effusion; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 18659110 ↗
• InjuryJan 2, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 2 YEARS POST-OP DUE TO PAIN. DURING THE REVISION, IT WAS FOUND THAT THE TIBIAL IMPLANT WAS GROSSLY LOOSE WITH NO CEMENT ADHERED TO THE TITANIUM SURFACE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 18424438 ↗
• InjuryNov 29, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT WAS REVISED FOR KNEE PAIN APPROXIMATELY 5 YEARS POST IMPLANTATION. IT WAS FOUND THAT THE TIBIAL IMPLANT WAS LOOSE WITH NO CEMENT ADHERED TO THE TITANIUM SURFACE. TIBIAL IMPLANT WAS REVISED FOR LOOSENING AND THE ARTICULAR SURFACE AND FEMORAL IMPLANT WERE REVISED AS BEST PRACTICE.

  Patient problems: Pain

  MAUDE report 18233938 ↗
• InjuryJul 11, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain; Subluxation; Swelling/ Edema

  MAUDE report 17297400 ↗

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-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-0468-2023 · Dec 6, 2022 · Open, Classified
  NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01
• 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-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-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-2115-2017 · Apr 28, 2017 · Terminated
  NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
• Z-1147-2016 · Jan 11, 2016 · Terminated
  Product 49 consists of all product under product code: JWH and same usage: Item no: 597206529 NEXGEN ALL-POLY PATELLA, 597206532 NEXGEN ALL-POLY PATELLA, 597206535 NEXGEN ALL-POL

…and 80 more.