P.F.C. 86-5226Recalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 10603295216766), received between Jul 11, 2017 and Jan 5, 2026 — classified as 1 injury, 79 malfunctions.

The most frequently reported specific device problem is “Break” (41 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Material Deformation

  IT WAS REPORTED THAT THE PFC STEM TRIAL EXTRACT WAS BENT BUT DID NOT BREAK INTO TWO PIECES. THE EVENT DID NOT CAUSE ANY DELAY TO THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23961790 ↗
• MalfunctionJun 9, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEM WAS BENT AT THE TIP WHERE THE THREADS ARE LOCATED, THEREFORE WAS NOT THREADING WITH A STEM TRIAL. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166504 ↗
• MalfunctionNov 5, 2024Break; Break

  IT WAS REPORTED THAT A PART OF THE EXTRACTION INSTRUMENT BROKE APART. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20610146 ↗
• MalfunctionOct 16, 2024Break; Break

  THE THREADED END HAS BROKEN OFF AND DAMAGED INTO THE STEM TRIAL.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461975 ↗
• MalfunctionAug 22, 2024Material Deformation; Material Deformation

  THIS INSTRUMENT IS COMPOSED OF 1 PART. THE KNOB OF THE INSTRUMENT IS BENT. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20030280 ↗
• MalfunctionAug 9, 2024Material Deformation; Material Deformation

  THIS INSTRUMENT IS COMPOSED OF 1 PART. THE TOP OF THE INSTRUMENT IS BENT. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19948241 ↗
• MalfunctionJul 3, 2024Material Deformation; Material Deformation

  THIS INSTRUMENT IS COMPOSED OF 1 PART. THE TOP PART OF THE INSTRUMENT HAS A VISIBLE BENT NEAR THREADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19666288 ↗
• MalfunctionJul 1, 2024Break; Break

  IT WAS REPORTED THAT THE SCREWDRIVER TIP BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643994 ↗
• MalfunctionJun 14, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE INSTRUMENT HAS AN UNKNOWN ALLEGATION. THE EVENT DID NOT HAPPEN DURING SURGERY. ADDITIONAL EVENT INFORMATION: VISUAL INSPECTION OF THE RETURNED SAMPLE FOUND THAT TIP OF THE DEVICE IS BROKEN OFF. BROKEN FRAGMENT WAS FOUND STUCK INSIDE A PFC* FLUT TIB ROD TRL 75 X 14.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19543479 ↗
• MalfunctionMar 15, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TRIAL STEM EXTRACTOR TIP IS BENT. THE ALLEGATION DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18916259 ↗
• MalfunctionFeb 16, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE INSTRUMENT IS BENT AND TIP OF INSTRUMENT IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720357 ↗
• MalfunctionDec 16, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PFC STEM TRIAL EXTRACT WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18341690 ↗
• MalfunctionSep 28, 2023Material Deformation; Material Deformation

  THIS INSTRUMENT IS COMPOSED OF THE 1 PART. THE TIP OF THE INSTRUMENT HAS BEEN BENT. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17832854 ↗
• MalfunctionMar 17, 2023Break; Break

  IT WAS REPORTED THAT SHAFT HAS BECOME DISSOCIATED FROM HANDLE WHERE THE WELDING CONNECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16563616 ↗
• MalfunctionMar 15, 2023Break; Break

  IT WAS REPORTED THAT INSTRUMENT IS BROKEN. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16550699 ↗
• MalfunctionJan 12, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INSTRUMENT IS BENT. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16146863 ↗
• MalfunctionDec 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SHAFT DISCONNECTED FROM GRIP BLASTED SHAFT HOLDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16033793 ↗
• MalfunctionSep 8, 2022Break; Break

  IT WAS REPORTED THAT THE FLUTED ROD EXTRACTOR TIP BROKEN OFF FLUTED STEM END OF ROD EXTRACTOR BROKE INSIDE STEM. TIME ADDED ON ABOUT 20 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15380036 ↗
• MalfunctionDec 15, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE THREADS ARE STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13009691 ↗
• MalfunctionOct 19, 2021Break; Break

  DURING KNEE REVISION SURGERY TODAY THE ITEMS WERE DAMAGED TRYING TO REMOVE A STEM TRIAL STUCK IN THE TIBIA. THE END OF THE EXTRACTOR THAT SCREWS INTO THE STEM TRIAL BROKE OFF INSIDE THE STEM TRIAL. NO SIGNIFICANT DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662652 ↗
• MalfunctionOct 11, 2021Break; Break

  IT WAS REPORTED THAT THE TIP OF STEM EXTRACTOR WAS BROKEN WHILE TRYING TO REMOVE THE 16 MM STEM TRIAL. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605551 ↗
• MalfunctionApr 29, 2021Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED WAS RECEIVED INDICATED THAT THE SLEEVE TAPER EXTRACTOR HAD STRIPPED THREADS. THE STEM WRENCH FUNCTION HAD NOT BEEN LUBRICATED APPROPRIATELY MAKING THE ACTION STIFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11749428 ↗
• MalfunctionMar 8, 2021Break; Break

  IT WAS REPORTED THAT UPON INSPECTION OF INSTRUMENTS, IT WAS FOUND OUT THAT THE STEM TRIAL EXTRACTOR WAS BROKEN. THE INSTRUMENT WAS NOT USED IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11435461 ↗
• MalfunctionMar 4, 2021Crack; Crack

  EMAIL RECEIVED FROM CSSD DEPARTMENT AT (B)(6) HOSPITAL WITH A LIST OF BROKEN INSTRUMENTS. ALL INSTRUMENTS REMAIN IN ONE PIECE. DAMAGE IS THROUGH CRACKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11413368 ↗
• MalfunctionOct 28, 2020Break; Break

  STEM EXTRACTION TOOL TIP BROKE OFF INSIDE TRIAL STEM. ALL PIECES RECOVERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10747984 ↗