P.F.C. SIGMA 96-2012Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295240587), received between Aug 16, 2017 and Nov 1, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TIBIAL INSERT WAS REMOVED AND REPLACED FOR WEAR. THERE WAS NO PATIENT CONSEQUENCE, NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20590716 ↗
• InjuryNov 1, 2022Fracture; Naturally Worn; Fracture; Naturally Worn

  PATIENT HAD COMPLAINTS OF RIGHT KNEE PAIN. XRAYS APPEARED TO SHOW POLYETHYLENE WEAR ON MEDIAL SIDE. UPON RETRIEVAL OF INSERT IT WAS NOTED THERE WAS ¿PEELING¿ AND WEAR ON BOTH MEDIAL AND LATERAL SIDES OF THE POLY. THE WEAR WAS EXPECTED THE ¿PEELING/FLAKING¿ WAS NOT. DOI: (B)(6) 2007, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 15708823 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF PFC TKR FEMORAL, BEARING AND TIBIAL COMPONENTS REVISED FOR LOOSENING. INSTABILITY, OSTEOLYSIS. PRIMARY SURGERY DATE UNKNOWN HOWEVER IMPLANTED AT (B)(6)HOSPITAL BY DR (B)(6) PRE 2005. DOI: UNKNOWN. DOR: (B)(6) 2021. UNKNOWN SIDE.

  Patient problems: Joint Laxity; Osteolysis

  MAUDE report 12696675 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A RIGHT SIGMA TOTAL KNEE, DONE ¿SOMETIME IN 2012¿ PER SURGEON. PT WAS REVISED FOR PAIN, COMPONENTS WERE WELL FIXED, SURGEON CONVERTED TO POSTERIOR STABILIZED FEMUR COMPONENT. THE TIBIA COMPONENT WAS RETAINED AND NOT REMOVED. DOI: 2012. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12471050 ↗
• InjuryDec 4, 2017Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL KNEE. POLY WORN POSTERIOR LATERAL.

  Patient problems: Pain

  MAUDE report 7080205 ↗
• InjuryAug 16, 2017Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THERE WAS A FAILURE OF THE INSERT, DUE TO "CLUNK" NOISE COMING FROM THE KNEE. UPDATE 5-1-2017: MEDICAL RECORDS HAVE BEEN REVIEWED. PRIMARY OPERATIVE NOTE (B)(6) 2010 INDICATES THE PATIENT RECEIVED A RIGHT PFC TOTAL KNEE REPLACEMENT. NO COMPLICATIONS NOTED BY THE SURGEON. CLINICAL NOTES (B)(6) 2017 INDICATE THE PATIENT WAS BEING SEEN FOR INSTABILITY, PAIN, SWELLING AND CLUNKING OF THE RIGHT TOTAL KNEE REPLACEMENT. IT CAN BE GATHERED THAT THE REPORTED "CLUNK" IS MORE OF A SENSATION THAN A NOISE. REVISION OPERATIVE NOTES (B)(6) 2017 INDICATE DURING THE SURGERY THE SURGEON NOTED SEVERE POSTERIOR POLYETHYLENE WEAR, NO EVIDENCE OF INFECTION, COMPONENTS WERE WELL FIXED. THERE WAS ALSO NATURAL PATELLA BAJA WITH CHONDRAL DAMAGE. THE REVISION WAS COMPLETED WITHOUT ANY COMPLICATION NOTED BY THE SURGEON. REPORTABILITY HAS BEEN UPDATED. UPDATED 8-16-2017.

  Patient problems: Joint Swelling; No Code Available; Pain

  MAUDE report 6797660 ↗