P.F.C. SIGMA 96-1451Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295238676), received between Jan 5, 2018 and Mar 14, 2023 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2023Break; Break

  IT WAS REPORTED THAT INSERT TRIAL BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537117 ↗
• MalfunctionFeb 6, 2023Crack; Crack

  IT WAS REPORTED THAT THE INSERT TRIALS CRACKED. ALL PIECES RETRIEVED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16302917 ↗
• MalfunctionAug 25, 2022Break; Break

  TRIAL IS CHIPPED. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292697 ↗
• MalfunctionJun 21, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE TRIAL IS DAMAGED; CLIP INTO TIBIAL TRAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14758545 ↗
• MalfunctionMar 9, 2022Break; Break

  IT WAS REPORTED THAT 10MM SIZE 4 INSERT TRIAL SNAPPED IN TWO PIECES DURING CASE. ALL PIECES RETRIEVED FROM PATIENT. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13711190 ↗
• MalfunctionJan 29, 2020Break; Break

  UPON INSTRUMENT INSPECTION FOUND A 4/10-MM PS TRIAL WAS CHIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9643589 ↗
• MalfunctionJan 2, 2020Break; Break

  IT WAS REPORTED BY SPD THAT A SIGMA SIZE 4, 10MM INSERT TRIAL WAS BROKEN. SPECIFICALLY,A PIECE WAS CHIPPED AROUND THE PERIPHERY ON UNDERSIDE OF INSERT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9540654 ↗
• MalfunctionDec 11, 2019Break; Break

  IT WAS REPORTED THAT A PIECE OF THE PLASTIC WALL, WHERE THE TRIAL SITS INSIDE OF THE TIBIAL TRAY WAS BROKEN OFF. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9451141 ↗
• MalfunctionApr 30, 2018Break; Break

  IT WAS REPORTED THAT THE SURGEON HIT POLY TRIAL WITH AN OSTEOTOME AND A PIECE OF PLASTIC FRACTURED. NO DELAY OR HARM TO PATIENT. BROKE OFF SMALL PIECE OF TRIAL. IT WAS ALSO STATED ROUTINE PRIMARY CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7472894 ↗
• MalfunctionMar 20, 2018Break; Break

  IT WAS REPORTED THAT THE SIZE 4 10MM STABILIZED FB INSERT TRIAL BROKE DURING SURGERY. ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7352782 ↗
• MalfunctionJan 5, 2018Break; Break

  IT WAS REPORTED THAT THE SIZE 4-10MM SIGMA FB PS TRIAL INSERT WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7167133 ↗