NexGen® 5980-27-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00889024217560), received between Nov 18, 2019 and Dec 22, 2025 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 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: Joint Laxity; Pain

  MAUDE report 23863134 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT IS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A KNEE ARTHROPLASTY REVISION TO ADDRESS PAINT, INSTABILITY AND JOINT EFFUSION APPROXIMATELY FIVE (5) MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS.

  Patient problems: Insufficient Information; Joint Laxity; Joint effusion; Pain

  MAUDE report 22649106 ↗
• InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18419670 ↗
• MalfunctionSep 9, 2022Fracture; Difficult to Insert; Fracture; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE TIBIAL INSERT WOULD NOT SEAT ON THE TIBIAL TRAY. DURING ATTEMPTED PLACEMENT OF THE TIBIAL INSERT, A PIECE OF THE TIBIAL TRAY FRACTURED FROM THE TRAY AND WAS REMOVED FROM THE SURGICAL FIELD. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15395012 ↗
• InjuryFeb 8, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED TWO YEARS SEVEN MONTHS POST PROCEDURE DUE TO PAIN AND LOOSENING. INFECTION WAS ENCOUNTERED DURING THE REVISION ACCORDING TO HCP THROUGH REP COMMENT HOWEVER NO MEDICAL RECORDS ARE AVAILABLE TO CONFIRM. NO ADDITIONAL INFORMATION AVAILABLE

  Patient problems: Pain; Unspecified Infection

  MAUDE report 13482083 ↗
• InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS EXPERIENCING PAIN APPROXIMATELY TWO YEARS AFTER A KNEE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 13471367 ↗
• InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY THREE MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO PAIN, SWELLING, DIFFICULTY AMBULATING AND LIMITED RANGE OF MOTION. IN SPITE OF THE INTERVENTION, THE PATIENT CONTINUED TO EXPERIENCE THE SAME AND INCREASED SYMPTOMS. ADDITIONALLY, THE PATIENT EXPERIENCED CONTINUOUS WARMTH AND REDNESS TO THE SITE WHICH WAS RESISTANT TO ICE, ELEVATION, AND ANTIBIOTIC THERAPY. ALL CULTURES AND BLOODWORK WERE NEGATIVE FOR INFECTION. APPROXIMATELY ONE YEAR AND NINE MONTHS POST INITIAL IMPLANTATION, THE PATIENT WAS REVISED OF ALL COMPONENTS WITH IMPLANTATION OF AN ANTIBIOTIC SPACER WITH INTRA-OP FROZEN SECTION SPECIMENS CONCERNING FOR INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Impaired Healing; Inflammation; Osteopenia/ Osteoporosis; Pain; Subclinical Infection; Swelling/ Edema; Synovitis

  MAUDE report 13061376 ↗
• InjurySep 7, 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 12435165 ↗
• InjuryAug 26, 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 12370089 ↗
• InjuryAug 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DEVELOPED PAIN, STIFFNESS, AND LIMITED RANGE OF MOTION THAT WAS UNRESOLVED WITH A MANIPULATION UNDER ANESTHESIA. THE PATIENT UNDERWENT A REVISION APPROXIMATELY 3 YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 12356158 ↗
• InjuryMar 4, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY TWO YEARS POST-IMPLANTATION DUE TO LOOSENING AND PAIN.

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

  MAUDE report 9787159 ↗
• InjuryNov 18, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN, LOOSENING OF TIBIAL COMPONENT WITH RADIOLUCENCY ELEVEN MONTHS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 9335818 ↗

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-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-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-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.