P.F.C. SIGMA 96-0120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295232742), received between Jul 14, 2021 and Feb 9, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT UNDERWENT PRIMARY PATELLA FEMORAL JOINT REPLACEMENT IN (B)(6) 2015. ((B)(6) HOSPITAL) PATIENT HAS COMPLAINED THAT THIS PF JOINT HAS NEVER FELT GOOD AND HAS BEEN PAINFUL SINCE TIME INDEX SURGERY. A DECISION WAS MADE TO REVISE THE PF JOINT TO A TOTAL KNEE REPLACEMENT. ON OPENING THE KNEE, THE FEMORAL COMPONENT WAS FOUND TO BE LOOSE. PROGRESSION ON DISEASE WAS ALSO FOUND IN THE OTHER CONDYLES. THE FEMORAL COMPONENT AS WELL AS THE INSERT PATELLA COMPONENT WAS REMOVED AND A TOTAL JOINT I PLANTED. ((B)(6) HOSPITAL, (B)(6) 2022). DEPUY CEMENT WAS NOT UTILISED. THE FEMORAL COMPONENT WAS LOOSE AT THE CEMENT BONE INTERFACE WITH THE COMPONENT COMING LOOSE WITH THE CEMENT STILL ADHERED TO THE UNDERSIDE. DOI: (B)(6) 2015. DOR: (B)(6), 2022. UNKNOWN KNEE.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 13498071 ↗
• InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT TKA ABOUT 6 YEARS AGO. REVISION COMPLETED DUE TO PATIENT COMPLAINTS OF PAIN. ON OPENING THE KNEE, THE PF JOINT WAS FOUND TO BE WELL FIXED (BOTH THE FEMORAL AND THE PATELLA COMPONENT). ARTHRITIC CHANGES WERE NOTED IN THE OTHER COMPARTMENTS.

  Patient problems: Pain

  MAUDE report 13399769 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN, INFLAMMATION, INSTABILITY AND LOOSENING OF THE TIBIA COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2011 DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Inflammation; Joint Laxity; Pain

  MAUDE report 12169675 ↗