P.F.C. SIGMA 96-1440Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295238423), received between Jun 29, 2017 and Jun 23, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY VIA TKA FOR OA OF LEFT SIDE OF KNEE WITH TRIAL INSERT IN QUESTION. DURING SURGERY, WHEN THE SURGEON INSERTED THE TRIAL INSERT, PART OF THE TRIAL INSERT BROKE. HE IMMEDIATELY REMOVED IT AND CONFIRMED THAT THE CHIPPED DEBRIS AND INSERT WERE COMPATIBLE AND THAT IT DID NOT REMAIN IN THE BODY. THE SURGEON USED OTHER TRIAL INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050981 ↗
• MalfunctionJun 4, 2021Break; Break

  IT WAS REPORTED THAT DURING KNEE SURGERY, A TIBIAL INSERT TRIAL WAS BROKEN AT (B)(6) HOSPITAL. LOT# UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11938164 ↗
• MalfunctionJan 29, 2020Break; Break

  IT WAS REPORTED THAT THE 3:8MM SIGMA FB POLY TRIAL WAS INSERTED BY THE SURGEON DURING THE TRIALING PROCESS BEFORE IMPLANTING FOR A TKA. THE RIM AROUND THE INFERIOR ASPECT OF THE TRIAL WHERE IT SITS DOWN INTO THE TIBIAL TRAY BROKE. THE POLY TRIAL WAS DAMAGED WHILE REMOVING FROM THE TIBIAL TRAY TRIAL. ALL PIECES WERE RETRIEVED FROM THE PATIENT AND THERE WAS NO DELAY IN SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9644383 ↗
• MalfunctionJun 29, 2017Break; Break

  IT WAS REPORTED THAT UPON INSPECTION IT WAS DISCOVERED THAT THE RIDGE UNDERNEATH THE SIZE 3 8MM TIBIAL INSERT WAS BROKEN OFF/CRACKED.

  Patient problems: No Information

  MAUDE report 6677697 ↗