N/A 96-6884Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295496502), received between May 17, 2021 and Sep 15, 2021 — 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 16, 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.

• MalfunctionSep 15, 2021Break; Break

  IT WAS REPORTED THAT WHILE BROACHING THE TIBIA WITH A METAPHRAGMAL SLEEVE, THE LOCKING EXTENSIONS SHEARED OFF AND FELL INTO THE PATIENT. THEY WERE RETRIEVED. SURGICAL DELAY OF 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474149 ↗
• MalfunctionMay 17, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE REVISION KNEE SURGERY THE 34MM FEMORAL SLEEVE BROACH AND 14 X 115 STEM TRIAL GOT STUCK AND WAS HARD TO REMOVE. DURING THAT TIME THE REVISION FEMORAL BROACH HANDLE CAME OFF AND LANDED ON THE FLOOR. WE HAD TO GET IT RE-STERILIZED. WHILE WAITING THE SURGEON STARTED TRYING TO REMOVE WITH VICE GRIPS AND DAMAGED THE STEM TRIAL AND SLEEVE BROACH. WHEN WE DID GET THE HANDLE BACK IT WOULD NOT STAY ATTACHED TO THE BROACH SO I GUESS IT WAS DAMAGED AS WELL. ALL THREE INSTRUMENTS NEED REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832459 ↗