P.F.C. SIGMA 96-0828Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295234111), received between Aug 7, 2018 and Apr 13, 2022 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 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 14103983 ↗
• InjuryApr 13, 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 14103978 ↗
• InjuryMar 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN INFECTED LEFT KNEE. EXTRACTION OF COMPONENTS AND INSERTION OF ANTIBIOTIC SPACER WERE DONE. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE AFFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 13925414 ↗
• InjuryOct 5, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT WAS REVISED TO ADDRESS FALL, PAIN AND LOOSENING OF THE FEMUR TO FEMORAL COMPONENT AND BOLT TO FEMORAL ADAPTOR AT THE BONE TO CEMENT AND CEMENT TO IMPLANT.

  Patient problems: Not Applicable; Pain

  MAUDE report 7940080 ↗
• 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 7756882 ↗