NexGen® 5986-47-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00889024218857), received between Dec 19, 2019 and Feb 8, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (16 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 8, 2026Loosening of Implant Not Related to Bone-Ingrowth

  NO ADDITIONAL INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Aseptic loosening; Joint Laxity; Pain

  MAUDE report 24288360 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT AND SUBSEQUENTLY EXPERIENCED PAIN AND RESTRICTED MOBILITY IN HIS KNEE WHICH IS BECOMING WORSE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 24233837 ↗
• InjuryNov 10, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING AND PAIN APPROXIMATELY 4.5 YEARS POST-OP. THE TIBIAL COMPONENT WAS FOUND TO BE GROSSLY LOOSE WITH NO CEMENT ADHERED TO THE TITANIUM SURFACE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 23509233 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE THREE YEARS POST IMPLANTATION DUE TO PAIN, SWELLING, HYPERTENSION AND INSTABILITY IN KNEE. ALL IMPLANTS, EXCEPT THE PATELLA, WERE REVISED WITHOUT COMPLICATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Fall; Swelling/ Edema

  MAUDE report 21917477 ↗
• InjuryJan 10, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT IS EXPERIENCING SWELLING, CLUNKING AND LOOSENING POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

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

  MAUDE report 21123555 ↗
• InjurySep 25, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING AND PAIN. ALL COMPONENTS EXCEPT THE PATELLA WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 20300025 ↗
• InjurySep 5, 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: Ambulation or Postural Difficulties; Insufficient Information; Loss of Range of Motion; Pain

  MAUDE report 20143731 ↗
• InjuryAug 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY PATIENTS¿ LEGAL COUNSEL THAT THE PATIENT UNDERWENT A KNEE REVISION PROCEDURE APPROXIMATELY 7 YEARS POST-IMPLANTATION. WHILST WALKING THE COMPONENT FAILED AND OUR CLIENT HAS SUFFERED VERY SERIOUS INJURY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 20051174 ↗
• InjuryAug 23, 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 SEVEN YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Arthritis; Aseptic loosening; Cyst(s); Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 20049891 ↗
• InjuryJun 18, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL BILATERAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 1 YEAR POST-OP, THE PATIENT DEVELOPED RIGHT-SIDED PAIN AND TIBIAL LOOSENING WAS NOTED BOTH ON XRAY AND INTRA-OPERATIVELY. SUBSEQUENTLY, THE PATIENT WAS REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 19562970 ↗
• InjuryJun 18, 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 FURTHER REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING AND PAIN. THE FEMORAL AND POLY COMPONENTS WERE ALSO REVISED. THE SURGEON NOTED THAT UPON REMOVING THE TIBIA, IT HAD SOME CEMENT BONDED TO THE SURFACE OF THE IMPLANT WITH VIRTUALLY NONE AROUND THE KEEL. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 19561047 ↗
• InjuryMay 21, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO PAIN, LOOSENING, AND POSSIBLE INFECTION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant; Pain; Unspecified Infection

  MAUDE report 19365093 ↗
• InjuryApr 29, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT CLAIMS THEY REQUIRE A REVISION PROCEDURE FOR AN UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19202024 ↗
• InjuryApr 10, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY THREE YEARS POST-IMPLANTATION, THE PATIENT PRESENTED WITH ONGOING KNEE PAIN AND DIFFICULTY WALKING DUE TO A DEEP TISSUE INFECTION. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY WHERE A LOOSE TIBIAL COMPONENT WAS ALSO REVEALED. FOLLOWING REVISION SURGERY, THE PATIENT CONTINUED WITH ONGOING ANTIBIOTIC TREATMENT FOR THE INFECTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Pain; Unspecified Infection

  MAUDE report 19080222 ↗
• InjuryMar 19, 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 5 YEARS POST IMPLANTATION DUE TO PAIN AND TIBIAL LOOSENING. THE TIBIAL IMPLANT WAS FOUND TO BE GROSSLY LOOSE WITH NO CEMENT ADHERED TO TITANIUM SURFACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 18937346 ↗
• InjuryMar 19, 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 5 YEARS POST IMPLANTATION DUE TO PAIN. THE TIBIA IMPLANT WAS FOUND TO BE GROSSLY LOOSE WITH NO CEMENT ADHERED TO TITANIUM SURFACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 18932109 ↗
• InjuryJan 30, 2024Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Bone Fracture(s); Failure of Implant; Insufficient Information; Joint effusion; Pain; Radiolucent Lines; Swelling/ Edema; Synovitis

  MAUDE report 18610055 ↗
• InjuryNov 17, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE SIX YEARS POST IMPLANTATION DUE TO PAIN AND TIBIAL LOOSENING. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 18158357 ↗
• InjuryFeb 21, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO TIBIAL LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Failure of Implant; Osteolysis; Pain; Radiolucent Lines

  MAUDE report 16412312 ↗
• InjuryAug 26, 2020Loss 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 A STUDY PATIENT IS SCHEDULED FOR A REVISION DUE TO TIBIAL LOOSENING. TIBIAL BASEPLATE LOOSENING WAS NOTED APPROXIMATELY NINE AND A HALF MONTHS¿ POST IMPLANTATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Information

  MAUDE report 10453663 ↗
• InjuryDec 19, 2019Loss 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

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

  Patient problems: No Information

  MAUDE report 9495378 ↗

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-0469-2023 · Dec 6, 2022 · Open, Classified
  NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02
• 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-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-0471-2023 · Dec 6, 2022 · Open, Classified
  NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02
• 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-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-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-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-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-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.