NA 00-5850-042-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024195929), received between Jan 22, 2020 and Aug 31, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PERIPROSTHETIC FEMUR FRACTURE AFTER A FALL APPROXIMATELY THREE (3) WEEKS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 17660792 ↗
• InjuryJan 10, 2023Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY ONE YEAR AND SEVEN MONTHS POST IMPLANTATION DUE TO PAIN, SWELLING, AND INSTABILITY. NOTED DURING THE REVISION IMPLANT FRACTURE, METAL DEBRIS, AND INFLAMMATORY TISSUE. THE FEMUR, HINGE MECHANISM AND STEM EXCHANGED WITH UNKNOWN PRODUCTS WITHOUT COMPLICATIONS.

  Patient problems: Cancer; Failure of Implant; Fall; Pain; Swelling/ Edema

  MAUDE report 16130606 ↗
• InjurySep 29, 2022Unstable; Migration; Unstable; Migration

  IT WAS REPORTED THAT X-RAY SHOWED THAT THE SEGMENTAL HINGE PIN AND CAP WERE OUT APPROXIMATELY 4 MONTHS AFTER THE IMPLANTATION. THIS CREATED INSTABILITY AND HAD TO BE REVISED. THE REVISION WENT WELL.

  Patient problems: Failure of Implant

  MAUDE report 15502442 ↗
• InjuryDec 22, 2020Adverse 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: Unspecified Infection

  MAUDE report 11059477 ↗
• 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. THE UNSTERILE/OPENED ITEM NEEDED TO BE RE-STERILIZED ASAP DURING THE FIRST SURGERY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9980792 ↗
• InjuryJan 22, 2020Unstable; Unstable

  IT WAS REPORTED THAT APPROXIMATELY 18 MONTHS POST IMPLANTATION, THE PATIENT EXPERIENCED A FALL AND SUFFERED PAIN AND INSTABILITY. UPON X-RAY IMAGING, IT WAS IDENTIFIED THAT THE YOKE HAD FRACTURED. SUBSEQUENTLY, THE PATIENT WAS REVISED AND ALL FRACTURED COMPONENTS WERE EXCHANGED. DURING THE REVISION, THERE WAS FLUID NOTED IN THE KNEE JOINT AND DAMAGE NOTED TO THE POLY BEARING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fall; Pain

  MAUDE report 9616060 ↗