NA 00-5850-043-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024195950), received between Apr 21, 2020 and Dec 10, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 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: Joint Laxity

  MAUDE report 20896050 ↗
• InjuryApr 2, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE EIGHTEEN MONTHS POST IMPLANTATION DUE FEMORAL LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19018719 ↗
• InjuryNov 29, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY 1.5 YEARS POST IMPLANTATION DUE TO LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18234837 ↗
• InjuryFeb 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY ONE YEAR AND EIGHT MONTHS POST IMPLANTATION DUE TO DISASSOCIATION OF THE HINGE PIN AND LOCKING CAP ON THE SEGMENTAL DISTAL FEMUR. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552350 ↗
• MalfunctionApr 21, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT SOME OF THE IMPLANTS IN THE LOANER SET WERE DELIVERED UNSTERILE. THE PACKAGING BOX WAS CLOSED WITH ADDITIONAL TRANSPARENT ADHESIVE TAPE. THE FIRST PLASTIC BOX INSIDE WAS CLOSED WITH THE SAME TAPE. THE WHITE TOP COVER PAPER WAS NOT HERMETICALLY CLOSED. SECOND PLASTIC BOX´S TOP COVER PAPER WAS OPENED TOO. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Patient Involvement

  MAUDE report 9980859 ↗