P.F.C. SIGMA 97-2101Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295250876), received between Mar 26, 2024 and Mar 28, 2024 — classified as 3 injuries.

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.

• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD ON 12 MAR 2024 WAS REVIEWED BY CLINICIAN. ON (B)(6) 2014, THE PATIENT HAD A BILATERAL CEMENTED TOTAL KNEE ARTHROPLASTY TO ADDRESS, BILATERAL KNEE PAIN AND BILATERAL KNEE OSTEOARTHRITIS END-STAGE. ALL COMPONENTS IMPLANTED WERE DEPUY PRODUCTS, INCLUDING THE CEMENT AND PATELLA. ON (B)(6) 2020, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY, TO ADDRESS MECHANICAL LOOSENING OF INTERNAL RIGHT KNEE PROSTHETIC JOINT. THE SURGEON REPORTED FINDING TIBIAL TRAY LOOSENING. THE FEMORAL COMPONENT WAS WELL FIXED, BUT THERE WAS SIGNIFICANT OSTEOLYSIS BEHIND THE FEMORAL IMPLANT WITH LARGE CAVITARY DEFECT. SIGNIFICANT SYNOVITIS WAS ALSO NOTED. COMPETITOR PRODUCTS WERE IMPLANTED DURING THIS PROCEDURE. DOI: (B)(6) 2014. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 18993082 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE LITIGATION COMPLAINT RECEIVED AD 12 MAR 2024 WAS REVIEWED BY THE CLINICIAN. ON (B)(6) 2014, THE PATIENT HAD A BILATERAL CEMENTED TOTAL KNEE ARTHROPLASTY TO ADDRESS, BILATERAL KNEE PAIN AND BILATERAL KNEE OSTEOARTHRITIS END-STAGE. ALL COMPONENTS IMPLANTED WERE DEPUY PRODUCTS, INCLUDING THE CEMENT AND PATELLA. ON (B)(6) 2021, THE PATIENT WAS REVISED DUE TO LEFT TOTAL KNEE ARTHROPLASTY, TO ADDRESS THE GROSS FAILURE OF THE TIBIAL TRAY WITH A WELL FIXED FEMORAL AND PATELLA COMPONENT. PRIOR TO SURGERY, THE PATIENT EXPERIENCED PAIN, INSTABILITY, AND DIFFICULTY AMBULATING. DURING THE PROCEDURE, THE SURGEON OBSERVED THAT THE TIBIAL TRAY WAS GROSSLY LOOSE AND HAD COLLAPSED CAUSING SIGNIFICANT BONE LOSS ON THE ANTERIOR AND LATERAL ASPECT OF THE TIBIA. DURING THE PROCEDURE, THE SURGEON REPORTED THAT DURING IMPACTION A BONE FRACTURE ALONG THE LATERAL TIBIAL CORTEX WAS NOTED. THE TIBIAL TRAY, INSERT, AND FEMORAL COMPONENT WERE REVISED. DOI: (B)(6) 2014. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 18992300 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE 1ST CLEANING OF THE AFFECTED AREA DUE TO INFECTION AFTER PRIMARY SURGERY. THIS PC REPORTS A SECOND CLEANING OF THE AFFECTED AREA AND REVISION OF THE IMPLANT AFTER THE FIRST CLEANING OF THE AFFECTED AREA. IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE PRIMARY SURGERY. AT THE END OF 2023 (DATE UNKNOWN) BECAUSE INFECTION WAS SUSPECTED, THE PATIENT WAS TREATED FOR CLEANING OF THE AFFECTED AREA. ON AN UNKNOWN DATE, THE MCL (MEDIAL COLLATERAL LIGAMENT) WAS CONFIRMED TO BE OPEN. AND THE PATIENT ORIGINALLY HAD MALIGNANT RA. THEREFORE, ON (B)(6) , THE AFFECTED AREA WAS CLEANED, AND THE IMPLANTS WERE FINALLY REMOVED AND REPLACED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 18978475 ↗