P.F.C. 86-6884Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295217664), received between Jan 9, 2018 and Sep 10, 2020 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2020Break; Break

  KNEE REVISION TRIAL BROKE APART IN PATIENT TIBIAL CANAL. BROKEN PIECE WAS REMOVED BY SURGEON.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10516409 ↗
• MalfunctionAug 19, 2020Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 115X14 STEM TRIAL FOUND BROKEN. WILL NOT ATTACH. NO REPORTED PATIENT CONSEQUENCES OR SURGICAL DELAYS.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10427081 ↗
• MalfunctionAug 19, 2020Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 115X14 STEM TRIAL FOUND BROKEN. WILL NOT ATTACH. NO REPORTED PATIENT CONSEQUENCES OR SURGICAL DELAYS.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10427052 ↗
• MalfunctionOct 24, 2019Break; Break

  THE TIP BUSTED OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9234568 ↗
• MalfunctionAug 30, 2019Break; Break

  IT WAS REPORTED THAT ONE OF THE 14 MM X 115 MM STEM TRIAL ATTACHMENT NUBS WAS BROKEN OFF. WE USED THIS SIZE DURING THE CASE BUT DISCOVERED THE NUB WAS BROKEN WHEN IT WAS FIRST PICKED UP OUT OF THE PAN. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8949506 ↗
• MalfunctionJul 1, 2019Break; Difficult to Remove; Physical Resistance/Sticking; Break; Difficult to Remove; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE STEM INSERTER TIP BROKE OFF INSIDE TRIAL STEM. BOTH PIECES RETRIEVED AND NO SURGICAL DELAY HAPPEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8750517 ↗
• MalfunctionMay 17, 2019Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE TRIAL STEM CAME OFF TIBIAL REAMER DURING SURGERY. EXTRACTION TOOL WAS BEING USED TO REMOVE THE STEM WHEN THE THREADED PORTION BROKE OFF THE HANDLE IN THE TRIAL STEM. THEY WERE ABLE TO GET THE TRIAL STEM OUT AND ALL PIECES WERE RECOVERED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8621586 ↗
• MalfunctionMar 15, 2018Break; Break

  IT WAS REPORTED THAT THE STEM BROKEN AND STUCK IN TIBIA 14X115, REMOVAL TOOL BROKE OFF WHEN TRYING TO RETRIEVE. NO PIECES OF BROKEN INSTRUMENTATION LEFT IN PATIENT. SURGICAL DELAY APPROXIMATELY 30 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 7341116 ↗
• MalfunctionJan 9, 2018Break; Break

  IT WAS REPORTED THAT WHILE REASSEMBLING THE INSTRUMENTS, IT WAS NOTICED THAT THE TWO PIECES WERE BROKEN. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7175468 ↗