NexGen® 5972-65-32 (REF 00-5972-065-32)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00889024215146), received between Mar 10, 2020 and Sep 22, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Insufficient Device Problem Information

  It was reported that the patient is experiencing unknown complications approximately nine (9) years following left knee arthroplasty.No additional information is available.

  Patient problems: Insufficient Information

  MAUDE report 50856577 ↗
• 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 23895898 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA PROCEDURE FIVE MONTHS POST IMPLANTATION DUE TO RANGE OF MOTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Loss of Range of Motion

  MAUDE report 21761085 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON RECEIPT OF ADDITIONAL INFORMATION, PATELLA WAS NOT REVISED DURING REVISION PROCEDURE. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 21404652 ↗
• InjuryJan 21, 2025Material Erosion; Fracture; Material Erosion; Fracture

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

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 21197989 ↗
• InjuryJan 6, 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: Insufficient Information

  MAUDE report 21085413 ↗
• InjuryOct 9, 2024Naturally Worn; Naturally Worn

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

  Patient problems: Synovitis

  MAUDE report 20411922 ↗
• InjuryOct 1, 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: Failure of Implant; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20344261 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED AS THIS WAS REVISION DUE TO LOOSENING OF THE TIBIA.

  Patient problems: Insufficient Information

  MAUDE report 18948453 ↗
• InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FOUR YEARS POST IMPLANTATION DUE TO PAIN. RADIOGRAPHIC SHOWS EVIDENCE OF FAILURE OF THE TIBIAL BASEPLATE WITH POSTEROMEDIAL COLLAPSE AND BONE LOSS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 16690954 ↗
• InjuryMar 24, 2023Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. APPROXIMATELY TWO YEARS POST IMPLANTATION, THE PATIENT PRESENTED WITH A CLUNK IN THE PATELLA AND ANTERIOR KNEE PAIN. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY OF THE PATELLA COMPONENT. DUE DILIGENCE IS COMPLETE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 16611134 ↗
• InjuryDec 22, 2021Noise, Audible; Noise, Audible

  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; Muscular Rigidity; Pain; Subclinical Infection; Swelling/ Edema; Synovitis

  MAUDE report 13061372 ↗
• InjuryAug 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY FOUR YEARS AND TEN MONTHS¿ POST IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 12348823 ↗
• InjuryJul 28, 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: Hypersensitivity/Allergic reaction

  MAUDE report 12240868 ↗
• InjuryJun 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY FOUR YEARS POST-IMPLANTATION DUE TO A DEFICIENT POSTERIOR CRUCIATE LIGAMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Damage to Ligament(s)

  MAUDE report 11976751 ↗
• 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: Ambulation or Postural Difficulties; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Muscular Rigidity

  MAUDE report 11266673 ↗
• InjurySep 3, 2020Fracture; Fracture

  UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE WAS REPORTED IN ERROR. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE CAUSE OF THE FALL WAS DUE TO A SLIP OF THE CONTRALATERAL LOWER EXTREMITY GOING DOWN STAIRS AND NO COMPONENTS WERE REMOVED THEREFORE; THE EVENT IS NOT DEVICE RELATED.

  Patient problems: No Information

  MAUDE report 10489028 ↗
• InjuryJul 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: No Information

  MAUDE report 10333031 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT DEVELOPED RIGHT DEEP VEIN THROMBOSIS APPROXIMATELY TWO WEEKS AFTER RIGHT TOTAL KNEE ARTHROPLASTY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Embolism

  MAUDE report 10255908 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY TWO YEARS LATER, THE PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA. THE PATIENT CONTINUED TO EXPERIENCE ONGOING INTERMITTENT PAIN, STIFFNESS, AND FEELING HER KNEE "LOCK-UP". PATIENT PLANS TO BE REVISED, BUT NO REVISION HAS BEEN REPORTED TO DATE.

  Patient problems: Cyst(s); Muscular Rigidity; Pain

  MAUDE report 9810784 ↗

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-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-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-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-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-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-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.