P.F.C. SIGMA 96-0823Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295234098), received between Aug 7, 2018 and Apr 20, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 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.

• InjuryApr 20, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO INFECTION AND LOOSENING OF THE TIBIAL TRAY AT THE BONE TO CEMENT INTERFACE AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. TWO DEPUY CEMENTS WERE USED. IMPLANTS WERE REMOVED AND INSERTION OF ANTIBIOTIC SPACER WAS PERFORMED. DOI: (B)(6) 2015. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 14159633 ↗
• InjuryOct 28, 2020Migration; Migration

  REVISED DUE TO SUBSIDENCE AND THE PATIENT¿S ANATOMY. THE INITIAL REVISION WAS PERFORMED IN (B)(6) OF 2016.

  Patient problems: No Code Available

  MAUDE report 10748401 ↗
• InjuryAug 7, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT WAS REVISED TO ADDRESS METALLOSIS AND LOOSENING OF THE STEM BOLT AND FEMUR AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT POLY SWAP SINCE DOING THE REVISION. DOI: (B)(6) 2001; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Tissue Damage

  MAUDE report 7756947 ↗
• InjuryAug 7, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT WAS REVISED TO ADDRESS METALOSIS AND LOOSENING OF THE STEM BOLT AND FEMUR AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT POLY SWAP SINCE DOING THE REVISION. DOI: (B)(6) 2001; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Tissue Damage

  MAUDE report 7756852 ↗