NA 201-25-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862042415), received between Mar 9, 2022 and Mar 9, 2022 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2022Break; Break

  AS REPORTED, DURING IMPACTION, THE SURGEON WAS ATTEMPTING TO TRIAL A TIBIAL INSERT. HE WAS HAVING SOME DIFFICULTY SEATING THE INSERT, SO HE TRIED IMPACTING IT WITH THE APPROPRIATE INSTRUMENT AND A SMALL PIECE BROKE OFF. ONE PIECE CAME OFF DURING IMPACTION AND WAS RETRIEVED. PATIENT WAS REVISED TO CR TIBIAL INSERT, SIZE 5, 15MM. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. PHOTO RECEIVED. THE DEVICE WILL BE RETURN. AS OF NOTE: "PATIENT REVISION REPORTED UNDER MFR# 1038671-2022-00211."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13712908 ↗