NA 201-02-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862041760), received between Jun 26, 2022 and Nov 29, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionNov 29, 2022Break; Break

  AS REPORTED, DURING TRIALING WITH THE 35MM PATELLA TRIAL, WHILE REMOVING THE PATELLA TRIAL ONE OF THE PATELLA PEGS BROKE OFF INSIDE THE PATIENT. THE SURGEON WAS ABLE TO REMOVE THE NUB USING A DRILL. THIS LED TO A SURGICAL DELAY OF ABOUT 5 MINUTES. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15883540 ↗
• MalfunctionJun 26, 2022Fracture; Fracture

  AS REPORTED, DURING USE THE PATELLA PEG HAS FRACTURED ON THE TRIAL. THERE WERE NO PIECES OF PARTS FELL INTO THE PATIENT WOUND SITE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE WILL BE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14823380 ↗