NexGen® 5980-47-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00889024217614), received between Sep 10, 2020 and Sep 29, 2026 — classified as 15 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (8 reports).

85 other recalls cover devices cleared under the same FDA submission (K173057, 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Manufacturing, Packaging or Shipping Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934181 ↗
• InjuryJan 22, 2026Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Arthrofibrosis; Aseptic loosening; Pain

  MAUDE report 24143559 ↗
• InjuryDec 2, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL KNEE SURGERY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT PRESENTED INFECTION AND LOOSENING OF TIBIAL AND FEMORAL COMPONENTS LEADING TO A REVISION SURGERY. THE SURGEON REMOVED ALL COMPONENTS AND REPLACED THEM WITH A SPACER. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Medical device site infection; Septic loosening

  MAUDE report 23695096 ↗
• InjurySep 11, 2025Adverse 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: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 23027977 ↗
• InjuryAug 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO TIBIAL IMPLANT FRACTURE AND JOINT INFECTION. IMPLANTS REMOVED AND CEMENT SPACER PLACED IN SITU TO CLEAR INFECTION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22911476 ↗
• InjuryNov 26, 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: Failure of Implant; Pain

  MAUDE report 20786853 ↗
• InjurySep 12, 2024Migration; Migration

  IT WAS REPORTED THE PATIENT UNDERWENT A KNEE PROCEDURE. APPROXIMATELY 7 YEARS POST-OP, THE PATIENT WAS REVISED DUE TO TIBIAL SUBSIDENCE. SURGEON NOTED THAT THE PATIENT WAS HIGHLY ACTIVE WHICH APPLIED A HUGE LOAD ON THE PATIENT'S KNEE. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 20205450 ↗
• InjurySep 5, 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 ARTHROPLASTY REVISION TO ADDRESS PERSISTENT PAIN, IMPLANT LOOSENING AND TIBIA PERIPROSTHETIC FRACTURE APPROXIMATELY ONE (1) YEAR FOLLOWING THE PATIENT'S LAST LEFT KNEE ARTHROPLASTY. ALL COMPONENTS WERE REMOVED AND REPLACED EXCEPT FOR THE PATELLAR COMPONENT. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES NOTED THAT DURING REMOVAL OF THE TIBIAL PLATE, THE LATERAL CORTEX OF THE TIBIA WAS NOTED TO BE SPLINTERED. FINAL COMPONENTS WERE PLACED WITHOUT COMPLICATIONS.

  Patient problems: Bone Fracture(s); Failure of Implant; Pain

  MAUDE report 20145318 ↗
• InjuryAug 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND SUSPECTED IMPLANT LOOSENING APPROXIMATELY FOUR (4) YEARS FOLLOWING THE PATIENT'S LAST LEFT KNEE ARTHROPLASTY. THERE ARE NO PLANS TO REVISE THE PATIENT AT THIS TIME AFTER NO COMPLICATIONS WITH THE IMPLANTS OR HEALING WERE IDENTIFIED. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain

  MAUDE report 20057073 ↗
• InjuryOct 1, 2021Fracture; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN AND LOOSENING APPROXIMATELY 6 YEARS 2 MONTHS POST PROCEDURE. CT SCAN OF RIGHT KNEE SHOWS SOME PERIPROSTHETIC LUCENCY AT MEDIAL POSTERIOR ASPECT OF TIBIAL COMPONENT SUGGESTIVE OF MILD LOOSENING NOTING. CT SCAN ONLY SHOWED MILD LYSIS UNDER THE TIBIAL PLATE MEDIAL. NO FALL OR MAJOR IMPACT REPORTED BY PATIENT. DURING EXPLANTATION OF TIBIA COMPONENT IT WAS APPARENT THAT THE TIBIA BASEPLATE WAS BROKEN ON THE MEDIAL ASPECT OF THE IMPLANT. NO ADDITIONAL INFORMATION

  Patient problems: Failure of Implant; Pain

  MAUDE report 12561643 ↗
• InjurySep 21, 2021Adverse 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; Pain

  MAUDE report 12505320 ↗
• MalfunctionSep 2, 2021Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414062 ↗
• InjuryApr 1, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  INITIAL LEFT TOTAL KNEE ARTHROPLASTY PERFORMED. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH A DVT IN THE LEFT LOWER EXTREMITY ONE WEEK POST PROCEDURE, AND RESOLVED ONE WEEK LATER. AT THE 1 MONTH FOLLOW UP, THE PATIENT DEMONSTRATED INSUFFICIENT FLEXION AND REPORTED DISSATISFACTION WITH AN INABILITY TO PERFORM USUAL ACTIVITIES. THE PATIENT STARTED PHYSICAL THERAPY FOR TREATMENT.

  Patient problems: Loss of Range of Motion; Thrombosis/Thrombus

  MAUDE report 11602419 ↗
• InjuryDec 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT APPROXIMATELY 1 MONTH POST IMPLANTATION, THE PATIENT WAS REVISED OF THE TIBIAL COMPONENTS DUE TO DISASSEMBLY OF THE ARTICULAR SURFACE AND TIBIAL TRAY. NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Code Available

  MAUDE report 11090262 ↗
• InjuryDec 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Failure of Implant; No Information

  MAUDE report 10929546 ↗
• InjurySep 16, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION TWO MONTHS AGO AFTER UNDERGOING AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY FOUR YEARS PRIOR, DUE TO PAIN AND LOOSENING OF THE TIBIAL PLATE AND FEMORAL COMPONENT. THE PATIENT HAD TO LIMIT ACTIVITIES DUE TO PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 10540582 ↗
• InjurySep 10, 2020Adverse 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: Embolism

  MAUDE report 10513243 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173057, 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-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-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-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-1159-2016 · Jan 11, 2016 · Terminated
  Product 61 consists of all product under product code: JWH and same usage: Item no: 598003712 STD PRECOAT TIBIA PLATE S for use in total knee 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
• 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
• 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
• Z-0590-2016 · Dec 3, 2015 · Terminated
  NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3. Tibial component of im
• Z-0449-2016 · Dec 2, 2015 · Terminated
  Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patie
• Z-2552-2014 · Jul 22, 2014 · Terminated
  Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD

…and 70 more.