K-15 PORK 74027432Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556769836), received between Apr 1, 2022 and Apr 1, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Premature Separation” (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.

• InjuryApr 1, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE DURING A TKA SURGERY AFTER DRILLING THE 5.7 LUG HOLES THE PATELLA WAS PRESSED INTO THE BONE USING THE POROUS OVAL PATELLA SZ 32MM. IT DID NOT STICK TO OR GRAB ANY BONE. WITH NO EFFORT, THE SURGEON REMOVED THE PATELLA BY LIGHTLY LIFTING WITH A FREER. THEY TRIED A SECOND TIME TO CLAMP AND PRESS INTO BONE, AND IT DID NOT TAKE A SECOND TIME. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, BY CEMENTING THE SAME DEVICE IN THE BONE. PATIENT WAS NOT HARMED BEYOND THE PROBLEM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13975577 ↗