P.F.C. SIGMA 96-1888Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295240402), received between Dec 13, 2017 and Nov 29, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2022Break; Break

  IT WAS REPORTED THAT THE TIBIAL A SLEEVE WRENCH BROKEN AND SIZE 4 8MM AUGMENT BROKE DURING TRAILING. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15876508 ↗
• MalfunctionNov 21, 2021Break; Break

  IT WAS REPORTED THAT THE SIZE 4 8MM POSTERIOR TRIAL AUGMENT HAS HAD THE ATTACHMENT PIECE AND BALSEAL BREAK OFF IN SPD. THEY DISPOSED OF THE MISSING PIECE. PLEASE SHIP REPLACEMENT TO MULLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12850142 ↗
• MalfunctionMar 27, 2020Break; Material Twisted/Bent; Naturally Worn; Break; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE ITEMS ARE WORN OR BROKEN. NO LONGER WORKING CORRECTLY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9889041 ↗
• MalfunctionMar 13, 2020Break; Break

  IT WAS REPORTED THAT THE POSTERIOR FEMORAL AUGMENT WAS BROKEN. THE BROKEN POST WAS STILL IN THE FEMORAL TRIAL. THIS DID NOT HAPPENED DURING THE CASE. THEY ASSUME SPD TRIED TO REMOVE THE TRIAL IMPROPERLY AND BROKE IT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831838 ↗
• MalfunctionMay 20, 2019Break; Break

  WHEN RESETTING INSTRUMENT TRAYS FROM THE DAYS PRIOR REVISION CASE THE SIGMA SIZE 4 POSTERIOR AUGMENT (8MM) BROKE OFF IN THE SIGMA SIZE 4 FEMORAL TRIAL. I ALSO HAD THE TRIAL EXTRACTOR FOR THE SIGMA UNIVERSAL STEMS BEND AND IS NOT LONGER USABLE. THE PATIENT WAS NOT AFFECTED BY THIS SINCE THIS ALL OCCURRED POST OP PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8625391 ↗
• MalfunctionMay 22, 2018Break; Break

  IT WAS REPORTED THAT THE BROKEN AUGMENT TRIALS FOUND IN WASH SIZE 3 8MM, SIZE 4 8MM, SIZE 5 8MM. PRODUCTS WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7533457 ↗
• MalfunctionFeb 26, 2018Break; Break

  IT WAS REPORTED THAT INSTRUMENTS BROKE DURING SURGERY. NO SURGICAL DELAY. NO PIECES OF INSTRUMENTATION WAS LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7297636 ↗
• MalfunctionDec 22, 2017Fracture; Fracture

  IT WAS REPORTED THAT THE SIZE 4 POSTERIOR 8MM AUGMENT TRIAL WAS NOTED TO BE BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7141693 ↗
• MalfunctionDec 13, 2017Break; Break

  IT WAS REPORTED THAT THE AUGMENT TRIAL WAS BROKEN. NO SURGICAL DELAY. ALL PIECES RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7113418 ↗