P.F.C. SIGMA 96-1361Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295237365), received between Jul 20, 2017 and Aug 17, 2021 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE CURVED INSERT TRIAL BROKE IN REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12332847 ↗
• MalfunctionMar 15, 2021Break; Scratched Material; Break; Scratched Material

  TWO OF THE HP PFC CURVED INSERTS HAVE BEEN DAMAGED THROUGH USE OVERTIME. A PIECE WAS BROKEN (CHIP) AND NOTHING WAS LEFT IN PATIENT. IT MAY HAVE OCCURRED IN THE CLEANING PROCESS AND THE SCRATCHES FROM REGULAR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11487860 ↗
• MalfunctionDec 17, 2019Break; Break

  IT WAS REPORTED THAT THE THREE SIGMA TIBIAL INSERTS WERE PULLED FROM SETS BY CENTRAL SUPPLY BECAUSE THEY HAD CRACKS IN THEM. NO PIECES WERE MISSING. ALL THREE INSERTS ARE BEING RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9483192 ↗
• MalfunctionNov 8, 2019Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT ALL TRIAL LINERS WAS BROKEN. ALL PIECES WERE RECOVERED FROM PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9296195 ↗
• MalfunctionSep 19, 2019Break; Break

  TRIAL INSERT BROKE UPON REMOVAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9089061 ↗
• MalfunctionMay 22, 2019Break; Break

  INSTRUMENT BROKE INTO TWO PIECES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8631597 ↗
• MalfunctionApr 4, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING REMOVAL OF 4X10MM INSERT TRIAL, A PIECE WAS BROKEN OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8483318 ↗
• MalfunctionApr 4, 2019Break; Break

  IT WAS REPORTED THAT THE POLY TRIAL WAS BROKEN WHILE REMOVING IT FROM THE KNEE AFTER THE CEMENT SET. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8483172 ↗
• MalfunctionApr 2, 2019Break; Break

  IT WAS REPORTED THAT THE INSERTS WERE BROKEN. NO SURGICAL DELAY HAPPEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8474871 ↗
• MalfunctionDec 4, 2018Break; Naturally Worn; Break; Naturally Worn

  TRIALS ARE WORN AND CHIPPED THROUGH MULTIPLE USE.

  Patient problems: No Code Available

  MAUDE report 8128881 ↗
• MalfunctionJul 20, 2017Break; Break

  IT WAS REPORTED THAT THE INSERT TRIAL CRACKED AND BROKE WHEN INSERTED.

  Patient problems: No Information

  MAUDE report 6730357 ↗