NexGen® 5988-12-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00889024221147), received between Sep 7, 2021 and Dec 22, 2025 — classified as 17 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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.

• 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 23863119 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 AVAILABLE.

  Patient problems: Joint Laxity; Joint effusion; Pain

  MAUDE report 23850867 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A RIGHT TOTAL ROTATING HINGE KNEE ARTHROPLASTY PERFORMED AND SUBSEQUENTLY UNDERWENT TWO REVISION SURGERIES DUE TO DISASSOCIATION OF THE HINGE POST EXTENSION AS WELL AS A QUADRICEPS TENDON REPAIR PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS CONTINUED TO EXPERIENCE SIGNIFICANT PAIN WHICH INTERFERES WITH AMBULATION AND DAILY ACTIVITIES FOR TWO (2) YEARS FOLLOWING THE MOST RECENT PROCEDURE. NO ADDITIONAL MEDICAL INTERVENTION HAS BEEN REPORTED TO DATE TO ADDRESS THE CONTINUED PAIN. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 20523353 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A RIGHT TOTAL ROTATING HINGE KNEE ARTHROPLASTY PERFORMED AND SUBSEQUENTLY UNDERWENT TWO REVISION SURGERIES DUE TO DISASSOCIATION OF THE HINGE POST EXTENSION. APPROXIMATELY THREE (3) WEEKS FOLLOWING THE SECOND REVISION SURGERY, THE PATIENT PRESENTED WITH SIGNIFICANT PREPATELLAR SWELLING AND UNDERWENT ADDITIONAL SURGERY TO REPAIR THE QUADRICEPS TENDON. DURING THE PROCEDURE, PREPATELLAR BURSITIS WAS REMOVED, AND TWO AREAS OF PARTIAL RUPTURE OF THE VASTUS MEDIALIS OFF THE QUADRICEPS TENDON WERE NOTED. THERE WERE NO CONCERNS WITH THE IMPLANTS WHICH WERE ALL RETAINED. THE TENDON WAS REPAIRED WITHOUT COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Bursitis; Muscle/Tendon Damage; Swelling/ Edema

  MAUDE report 20523340 ↗
• 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 20145415 ↗
• InjuryAug 7, 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 FIVE YEARS POST-IMPLANTATION DUE TO LOOSENING OF THE TIBIAL TRAY AND STEM. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 19931847 ↗
• InjuryJun 26, 2024Malposition of Device; Malposition of Device

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

  Patient problems: Failure of Implant; Joint effusion; Pain

  MAUDE report 19616158 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 19528968 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 18737729 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

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

  Patient problems: Ambulation or Postural Difficulties; Erosion; Hemothorax; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 18021898 ↗
• InjuryJun 29, 2023Adverse 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: Bacterial Infection; Erosion; Failure of Implant; Inflammation; Necrosis; Scar Tissue

  MAUDE report 17228756 ↗
• InjuryMar 29, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

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

  Patient problems: Failure of Implant

  MAUDE report 16636310 ↗
• InjurySep 12, 2022Loss 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 THAT A PATIENT WAS REVISED APPROXIMATELY TWO YEARS ONE AND A HALF MONTHS POST IMPLANTATION DUE TO PATIENT COMORBIDITIES, LIMITED RANGE OF MOTION, PAIN, SWELLING, AND LOOSENING. THE TIBIA COMPONENTS WERE REVISED WITH DIFFICULTY AND THE OSTEOTOMY WITH TIBIAL TUBERCLE WAS REAPPROXIMATED WITH CABLE WIRES. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

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

  MAUDE report 15402898 ↗
• InjuryJun 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT IS BEING CONSIDERED FOR A REVISION ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. 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 14686636 ↗
• 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 13482098 ↗
• 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 13471349 ↗
• 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 12435140 ↗

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-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-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-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-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-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-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.