P.F.C. 86-6875Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295217572), received between Dec 2, 2017 and Apr 21, 2025 — classified as 1 injury, 13 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT THE PEG ON STEM TRIAL BROKE. ALL PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21871991 ↗
• MalfunctionMar 24, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A KNEE REVISION SURGERY WAS PERFORMED AT (B)(6) HOSPITAL. DURING THE OPERATION, ROD "TRIAL" WAS USED TO CHECK THE FIT OF THE IMPLANTS. IN THE PATIENT'S LIMB PHOTO TAKEN TODAY, THE "TRIAL" ROD WAS OBSERVED AT THE BOTTOM OF THE LEG. AT THIS STAGE IT IS NOT KNOWN WHETHER THE INCIDENT AFFECTS THE PATIENT'S HEALTH AND / OR WHETHER FURTHER SURGERY IS PLANNED TO REMOVE THE TRIAL ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13890032 ↗
• MalfunctionOct 29, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SURGEON NOTICED THE INNER THREADS OF THE 12 X 75MM STEM TRIAL APPEARED TO BE BENT, AFTER UNSUCCESSFULLY TRYING TO THREAD IN THE STEM EXTRACTION TOOL. ALL PIECES WERE RETRIEVED AND BEING RETURNED. NO INSTRUMENTS WERE BROKEN. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12720124 ↗
• MalfunctionJul 28, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  CUSTOMER IS COMPLAINING THE INSTRUMENTS. THE TRIALS NO LONGER GET CLEAN. DIRT STILL COMES OUT OF THE GROOVES AT THE END OF THE TRIALS EVEN AFTER CLEANING. SEEN IN CSSD. NO PATIENT INVOLVEMENT, NO SURGERY DELAY. SEE ATTACHED PHOTOS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12240575 ↗
• MalfunctionJul 12, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT WHILE PERFORMING A REVISION KNEE USING THE SROM HINGED KNEE, THERE WAS A 12 X 75MM FLUTED TIBIAL TRIAL THAT WAS INADVERTENTLY LEFT IN THE FEMUR. THE SURGEON WAS USING THE FEMORAL BROACH REAMER WITH A 12 X 75MM FLUTED TIBIAL STEM TRIAL ATTACHED TO REAM THE DISTAL FEMUR FOR PREPARATION OF THE FEMORAL BROACHING WHEN APPARENTLY THE TRIAL STEM DETACHED FROM THE FEMORAL BROACH REAMER. IT WAS DISCOVERED AFTER A POST-OP XRAY THAT THE STEM TRIAL WAS INADVERTENTLY LEFT IN THE FEMUR AND WAS PUSHED ON UP THE FEMUR DURING PREPARATION AND IMPLANTATION OF THE ACTUAL IMPLANTS. THERE WAS NO RESISTANCE OR TROUBLE FINISHING THE PREPARATION AND IMPLANTATION OF THE FEMORAL COMPONENTS. UNSURE WHAT THE LOT NUMBER OF THE TRIAL STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12155718 ↗
• MalfunctionFeb 1, 2021Break; Break

  DURING A KNEE REVISION ARTHROPLASTY, THE SURGEON USED THE TIBIAL TRIAL WITH THE ROD AND WHEN HE TRIED TO TAKE THE TIBIAL TRIAL OUT, A PIECE OF THE ROD BROKE OFF AND STAYED IN THE TIBIAL SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11263148 ↗
• InjuryMar 5, 2019Break; Break

  INSTRUMENT WAS BROKEN DURING SURGERY CAUSING DELAY OF SURGERY TIME AND EXTRA PROCEDURE TO TAKE OUT THE INSTRUMENT FROM THE MEDULLARY CANAL.

  Patient problems: Not Applicable

  MAUDE report 8391410 ↗
• MalfunctionJan 10, 2019Break; Break

  TIBIAL TRIAL BROKE DURING SURGERY, THE TIP OF THE TRIAL STEM WAS FIXED IN THE TIBIAL CANAL, AND BROKE WHEN EXTRACTED. THEY TRIED TO EXTRACT THE TIP WITHOUT ANY LUCK.

  Patient problems: Not Applicable

  MAUDE report 8235838 ↗
• MalfunctionOct 16, 2018Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ROUTINE INSPECTION INDICATED PART WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7969627 ↗
• MalfunctionOct 11, 2018Break; Break

  IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT CAME OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7957037 ↗
• MalfunctionJul 2, 2018Break; Break

  IT WAS REPORTED THAT MBT STEM TRIAL PEGS ARE BROKEN. SHAPED OFF WHEN TESTING THEM IN SPD. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7654322 ↗
• MalfunctionMay 14, 2018Connection Problem; Material Deformation; Connection Problem; Material Deformation

  I WOULD LIKE TO REPORT BROKEN ITEMS WHICH WERE SENT OUT ON AN ORTHOKIT BOOKING: ORTHOKIT BOOKING NUMBER: (B)(4); SURGERY DATE: (B)(6) 2018; SURGEON: MR. (B)(6); OPERATION: TC3 MBT REVISION KNEE REPLACEMENT; HOSPITAL: (B)(6) HOSPITAL. INSTRUMENT TRAYS AFFECTED AND ITEM CODES: MODULE 1718 SIGMA FEMORAL SLEEVE KIT (B)(4); ITEM CODE AFFECTED: (B)(4) ADAPTOR TORQUE WRENCH . THE TORQUE WRENCH WAS NOT FIT FOR PURPOSE DURING THE OPERATION. IT DID NOT DAMAGE THE PATIENT OR IMPLANTS HOWEVER IT DID DELAY THE OPERATION BY 5 MINUTES. THE ISSUE WITH THE ITEM IS THAT IT DID NOT TORQUE THE STEM ONTO THE ADAPTOR SUFFICIENTLY. THE OUTCOME WAS FINE THOUGH IT MUST BE NOTED. MODULE 1655 ¿ TC3 REVISION KNEE (B)(4); ITEM CODE AFFECTED: (B)(4) PFC* FLUT TIB ROD TRL 75 X 12. THE 75 X 12 STEM DID NOT ATTACH TO THE TRIAL MBT TIBIAL TRAY WHICH AGAIN DID WAS NOT DETRIMENTAL TO THE PATIENT HOWEVER IT DID DELAY THE OPERATION BY 5 MINUTES. THE SURGEON THEN OPTED TO USE A 75 X 10 STEM TRIAL INSTEAD. PLEASE CAN THESE DEFECT ITEMS ON THE ORTHOKIT SETS BE REMOVED AND REPLACED. THEY ARE NOT FIT FOR PURPOSE.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7510246 ↗
• MalfunctionDec 2, 2017Break; Break

  DURING A KNEE REVISION SURGERY, THE TWO GUARDIAN SCIONS THAT HAD THE TEST STEM OF CT3 WERE BROKEN AND AT LEAST ONE OF THEM REMAINED IN THE PATIENT, THEY TRIED TO WITHDRAW BUT WERE NOT ABLE TO REMOVE IT. FOR THIS REASON THE SURGERY IS DELAYED ABOUT 5 MINUTES. PATIENT CONSEQUENCE: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7077893 ↗
• MalfunctionDec 2, 2017Break; Break

  DURING A KNEE REVISION SURGERY, THE TWO GUARDIAN SCIONS THAT HAD THE TEST STEM OF CT3 WERE BROKEN AND AT LEAST ONE OF THEM REMAINED IN THE PATIENT, THEY TRIED TO WITHDRAW BUT WERE NOT ABLE TO REMOVE IT. FOR THIS REASON THE SURGERY IS DELAYED ABOUT 5 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7077890 ↗