P.F.C. 86-6876Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295217589), received between Jul 21, 2017 and Sep 11, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Entrapment of Device; Device-Device Incompatibility; Entrapment of Device; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRIAL STEM WAS USED DURING CASE AND DID NOT APPEAR TO BE FAULTY AT THE TIME OF THE USE, HOWEVER IT DISCONNECTED FROM THE FEMORAL SLEEVE IN THE PATIENTS FEMUR AND HAS BEEN LEFT IN THE PATIENT. IT HAS BEEN PUSHED FURTHER UP THE FEMUR BY THE DEFINITIVE FEMORAL IMPLANTS. THE PATIENT HAD LOW BONE QUALITY AND WAS BEING REVISED TO A HINGE. THE TRIAL WILL REMAIN IN THE PATIENT. THERE IS NO PLAN TO REMOVE THE TRIAL STEM AS THIS WOULD BE MUCH MORE DAMAGING TO THE PATIENT THAN LEAVING IT IN SITU. THE PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS DOING WELL AND WENT HOME POST OP WITHIN A STANDARD TIME FRAME.

  Patient problems: Foreign Body In Patient

  MAUDE report 23027687 ↗
• MalfunctionSep 24, 2024Entrapment of Device; Mechanical Jam; Entrapment of Device; Mechanical Jam

  IT WAS REPORTED THAT DURING THE KNEE REVISION PROCEDURE A MANDREL, WHICH SHOULD BE INSERTED INTO THE FEMUR CHANNEL, WAS JAMMED. THE PROCEDURE WAS CARRIED OUT IN ACCORDANCE WITH THE OPERATING TECHNIQUE. AS A RESULT OF THE JAM, THE OPERATOR DECIDED TO KEEP THE ELEMENT INSIDE THE FEMUR CHANNEL. DUE TO ATTEMPTS TO PULL OUT THE ELEMENT, THE PROCEDURE LASTED NO MORE THAN 30 MINUTES. AT THE MOMENT THERE ARE NO CONSEQUENCES FOR THE PATIENT. THE REMAINING FINAL ELEMENTS HAVE BEEN INTRODUCED INTO THE FEMORAL CANAL IMPLANTS IN SUCH A WAY THAT DIRECT CONTACT OCCURS BETWEEN THE MEASURING ELEMENT AND THE IMPLANT. AN IMPLANT THAT CORRESPONDS TO THE STANDARD ELEMENT IS NOT USED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20289732 ↗
• MalfunctionMay 23, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DURING A KNEE REVISION A ZIMMER LCCK WAS TAKEN OUT AND A TC3 WAS GOING TO BE PUT IN. DURING THE PREPARATION OF TIBIA THEY HAD REAMED WITH THE 14 MM REAMER TO THE RIGHT DEPTH AND WITH THE CONICAL REAMER AND WENT ON TO BROACH WITH THE SMALLEST SLEEVE BROACH AND THE 14 X 75 MM STEM ATTACHED. DURING THE FIRST BROACH THE TIP OF THE TRIAL STEM CAME OFF THE TRIAL STEM AND GOT STUCK DISTALLY IN THE PATIENTS TIBIA. IT WAS NO CHANCE OF RETRIEVING IT BECAUSE IT WAS STUCK. THE TIP OF THE STEM IS NOT POSSIBLE TO LOOSEN BUT IT CAME OFF ANYWAY. THERE WAS A SURGICAL DELAY OF 45 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 14468721 ↗
• MalfunctionOct 31, 2019Break; Break

  ROUTINE INSPECTION INDICATED STEM TRIAL WAS SEPARATING AND IN NEED OF REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9262103 ↗
• MalfunctionJul 25, 2019Device-Device Incompatibility; Physical Resistance/Sticking; Device-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE STEM WOULD NOT SEAT IN EITHER REAMER. STEM ALSO BECAME STUCK IN REAMER. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826309 ↗
• MalfunctionOct 25, 2017Break; Break

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION, IT WAS NOTICED THAT THE PFC FLUT TIB ROD TRL 75 X 14 WAS BROKEN.

  Patient problems: No Information

  MAUDE report 6976086 ↗
• MalfunctionOct 6, 2017Break; Break

  IT WAS REPORTED THAT THE FLUTE TIBIA ROD TRIAL WAS BROKEN DURING THE CADAVER LAB TRAINING.

  Patient problems: No Information

  MAUDE report 6922364 ↗
• MalfunctionJul 21, 2017Break; Break

  IT WAS REPORTED THAT THE FLUTE TIBIAL ROD TRIAL BROKE OFF.

  Patient problems: No Information

  MAUDE report 6732083 ↗