NexGen® 5980-37-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00889024217584), received between Feb 2, 2021 and Dec 26, 2025 — classified as 23 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (13 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 23 most recent of 23 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 23895867 ↗
• InjuryDec 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT WAS HAVING PAIN AS A SYMPTOM. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 23790428 ↗
• InjuryDec 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. APPROXIMATELY 8.5 YEARS POST-OP, THE PATIENT WAS REVISED DUE TO LOOSENING. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening

  MAUDE report 23705570 ↗
• InjuryOct 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 6 YEARS POST IMPLANTATION OF A PRIMARY RIGHT TOTAL KNEE ARTHROPLASTY THE PATIENT WAS REVISED DUE TO LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE FROM THE REPORTER.

  Patient problems: Aseptic loosening

  MAUDE report 23290672 ↗
• InjuryAug 21, 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: Ambulation or Postural Difficulties; Aseptic loosening; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 22862254 ↗
• InjuryJul 9, 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: Cyst(s); Pain; Septic loosening; Unspecified Infection

  MAUDE report 22460760 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT FELL AND FRACTURED THEIR TIBIA APPROXIMATELY 1 YEAR AGO. THE PATIENT WAS REVISED. IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING PAIN AND INSTABILITY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Fall; Pain

  MAUDE report 21323034 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY SEVEN (7) YEARS AND NINE (9) MONTHS POST-IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21085403 ↗
• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE PROCEDURE. SUBSEQUENTLY, A FEW WEEKS POST-IMPLANTATION, THE PATIENT TWISTED THEIR KNEE. THE PATIENT WAS REVISED TO PAIN.

  Patient problems: Pain

  MAUDE report 18400843 ↗
• InjuryNov 13, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18124502 ↗
• InjuryOct 27, 2023Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

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

  Patient problems: Ambulation or Postural Difficulties; Erosion; Failure of Implant; Hemothorax; Pain; Radiolucent Lines; Swelling/ Edema; Unspecified Infection

  MAUDE report 18021782 ↗
• InjuryOct 4, 2023Loosening 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 17868158 ↗
• InjuryMay 2, 2023Fracture; Migration; Fracture; Migration

  IT WAS REPORTED VIA A COMPETENT AUTHORITY USER REPORT THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, SIX (6) YEARS POST-IMPLANTATION, THE PATIENT EXPERIENCED A FRACTURE OF THE TIBIAL COMPONENT. A REVISION SURGERY WAS PERFORMED IN WHICH THE COMPLETE PROSTHESIS SYSTEM WAS REPLACED. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN REPORTED.

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

  MAUDE report 16854706 ↗
• InjuryFeb 15, 2023Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY THREE YEARS POST-IMPLANTATION DUE TO TIBIAL TRAY LOOSENING AND MALROTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 16378320 ↗
• InjuryJan 10, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA PATIENT'S LEGAL COUNSEL THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SINCE IMPLANTATION THE PATIENT HAS EXPERIENCED CONTINUOUS PAIN AND DIFFICULTY WITH MOBILITY. CONTINUATION OF PRESCRIPTION PAIN MEDICATION DID NOT RELIEVE THE PATIENT'S SYMPTOMS. APPROXIMATELY FOUR YEARS POST IMPLANTATION, XRAY IMAGES REVEALED LOOSENING OF THE MEDIAL TIBIAL PLATEAU AND A DIAGNOSTIC ARTHROSCOPY FOUND SYNOVITIS FROM POLYETHYLENE ABRASION DEPOSITS IN THE JOINT. CULTURES AND TISSUE SAMPLES SHOWED NO EVIDENCE OF INFECTION. THE PATIENT IS SCHEDULED FOR AN UPCOMING REVISION SURGERY DUE TO ASEPTIC LOOSENING AND POLYETHYLENE BEARING WEAR. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Arthralgia; Failure of Implant; Inadequate Pain Relief; Pain; Scar Tissue; Synovitis

  MAUDE report 16132756 ↗
• InjurySep 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO IMPLANT FRACTURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392180 ↗
• InjuryMay 26, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TKA. APPROXIMATELY 5.5 YEARS LATER, THE PATIENT HAD TAKEN A COUPLE OF FALLS AND UPON EXAMINATION BY THE SURGICAL STAFF, THEY FELT THAT THE POLY HAD LOOSENED AND DISENGAGED FROM THE TIBIA. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2 DAYS AFTER THE FALL. THE TIBIA AND POLY WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Fall

  MAUDE report 14515488 ↗
• InjuryApr 1, 2022Loosening 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 REVISION RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY ONE YEAR POST IMPLANTATION, THE PATIENT REPORTED INCREASING PAIN. UPON X-RAY REVIEW, THE SURGEON NOTED THE TIBIA APPEARS TO HAVE SUBSIDED WITH SOME RADIOLUCENT LINES PRESENT SUGGESTING LOOSENING. THE PATIENT EVENTUALLY UNDERWENT REVISION SURGERY ONE YEAR AND TEN MONTHS POST IMPLANTATION DUE TO ASEPTIC LOOSENING AND SUBSIDENCE OF THE TIBIAL COMPONENTS. ALL COMPONENTS WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 13976697 ↗
• InjuryJun 2, 2021Adverse 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; Loss of Range of Motion; Muscle/Tendon Damage; Pain; Swelling/ Edema

  MAUDE report 11923925 ↗
• InjuryJun 2, 2021Adverse 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; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 11921592 ↗
• InjuryApr 30, 2021Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth; Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Pain; Scar Tissue

  MAUDE report 11753417 ↗
• InjuryApr 21, 2021Loosening 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 11699901 ↗
• InjuryFeb 2, 2021Adverse 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 11268061 ↗

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-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-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-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-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-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-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-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.