NEXGEN® TRABECULAR METAL® 00-5878-065-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00889024309814), received between Oct 25, 2019 and Mar 20, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Fracture” (6 reports).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY TWO (2) YEARS POST-IMPLANTATION AFTER EXPERIENCING A FALL THAT RESULTED IN THE POST OF THE NEXGEN PATELLA FRACTURING. DURING THE REVISION, THE PATELLA WAS EXPLANTED; HOWEVER, THE FRACTURED PEG PORTION WAS UNABLE TO BE REMOVED AND REMAINS IN THE PATIENT. NO OTHER PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 24650116 ↗
• InjuryMar 13, 2026Fracture

  IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO THE PATELLA FRACTURING AFTER THE PATIENT WAS WEIGHT BEARING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24597835 ↗
• InjuryDec 22, 2025Fracture; Fracture

  UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THIS ITEM WAS REPORTED UNDER THE WRONG MFR. THE REPORT WILL BE SUBMITTED UNDER MFR 3005751028.

  Patient problems: Insufficient Information

  MAUDE report 23863436 ↗
• InjuryOct 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION DUE TO PATELLA IMPLANT FRACTURE APPROXIMATELY TWO (2) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303703 ↗
• InjurySep 26, 2024Fracture; Fracture

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

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 20310322 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION FOR PATIENT PAIN. THE FEMUR, TIBIA, PATELLA AND POLY WERE REMOVED AND NEW REVISION PRODUCTS IMPLANTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Pain

  MAUDE report 18467647 ↗
• InjurySep 7, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Insufficient Information

  MAUDE report 17699148 ↗
• InjurySep 7, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Insufficient Information

  MAUDE report 17699126 ↗
• InjurySep 1, 2022Loosening 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. SUBSEQUENTLY, THE TIBIAL, FEMORAL, AND PATELLAR COMPONENTS WERE REVISED APPROXIMATELY 1 YEAR LATER DUE TO POSSIBLE ASEPTIC LOOSENING. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 15334039 ↗
• InjuryJul 7, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT UNDERWENT A KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED ONE YEAR POST PROCEDURE DUE TO HOT CT SCAN. TM PATELLA HOT (LOOSE) ON CT SCAN - REMOVED AND REPLACED WITH CEMENTED PATELLA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14944592 ↗
• InjurySep 23, 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: Adhesion(s); Loss of Range of Motion; Scar Tissue

  MAUDE report 12522496 ↗
• InjuryMay 13, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11819217 ↗
• InjuryFeb 11, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS POST IMPLANTATION, THE PATIENT WAS EXPERIENCING STIFFNESS AND CONSEQUENTLY UNDERWENT A MANIPULATION UNDER ANESTHESIA WITH INJECTION OF THE RIGHT KNEE. APPROXIMATELY 2 WEEKS POST MANIPULATION, THE PATIENT'S SWELLING HAD REPORTEDLY RESOLVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 9693534 ↗
• InjuryOct 25, 2019Unstable; Unstable

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

  Patient problems: Extraskeletal ossification; Loss of Range of Motion; Pain; Swelling

  MAUDE report 9239584 ↗
• InjuryOct 25, 2019Unstable; Naturally Worn; Unstable; Naturally Worn

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

  Patient problems: Extraskeletal ossification; Loss of Range of Motion; Pain; Swelling

  MAUDE report 9239576 ↗