NA 201-02-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862041777), received between Jul 8, 2021 and Jul 13, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2022Break; Break

  IT WAS REPORTED THAT DURING A LEFT TKR, THIS EVENT HAPPENED WHEN THE SURGEON STARTED TRIALING THE IMPLANTS. WHILE REMOVING THE 38MM PATELLA A PEG SNAPPED OFF INSIDE THE PATIENT. THE SURGEON TRIED TO REMOVE THE PEG WITH VARIOUS INSTRUMENTS WITHOUT ANY SUCCESS AND EVENTUALLY HAD TO REDRILL THE HOLE TO REMOVE THE PEG. NO PARTS OR PIECES WERE LEFT IN THE PATIENT. THERE WAS A LESS THAN 5 MIN DELAY THAT DID NOT RESULT IN AN ADVERSE EVENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL BE RETUNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14999054 ↗
• MalfunctionJul 8, 2021Break; Break

  AS REPORTED, DURING SURGICAL USE, THE BROKEN LUG WAS LODGED IN THE PATELLA AND IT WAS REMOVED. THE FEMALE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THERE WAS APPROXIMATELY A 5 MINUTE DELAY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISPOSED BY HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12138993 ↗