P.F.C. SIGMA 96-0903Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295234494), received between Jun 26, 2017 and Oct 9, 2020 — classified as 6 injuries.

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

• InjuryOct 9, 2020Off-Label Use; Off-Label Use

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMUR BOLT AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A 2 STAGE BILATERAL KNEE REPLACEMENT REVISION SURGERY APPROXIMATELY 5 YEARS AGO AT THE (B)(6) IN (B)(6). PATIENT WAS ALLERGIC TO BONE CEMENT SO THE REVISION WAS DONE WITH SIGMA FEMORAL SLEEVES AND TC3 FEMURS WITH A MBT REVISION TIBIA WITH SLEEVES ON BOTH THE RIGHT AND LEFT WITHOUT USING CEMENT. FEMUR ON RIGHT SIDE WAS UNSUPPORTED BY BONE AND HAD DEVELOPED METAL DEBRIS FROM THE ZERO BOLT AND SLEEVE ADAPTER. SURGEON REMOVED FEMUR AND REPLACED WITH A DISTAL FEMUR ON THE RIGHT SIDE. SLEEVES ON BOTH SIDES WERE WELL FIXED ON THE RIGHT SIDE. DOI: (B)(6) 2015. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10656256 ↗
• InjuryOct 9, 2020Off-Label Use; Off-Label Use

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMUR BOLT AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A 2 STAGE BILATERAL KNEE REPLACEMENT REVISION SURGERY APPROXIMATELY 5 YEARS AGO AT THE HSS IN NEW YORK. PATIENT WAS ALLERGIC TO BONE CEMENT SO THE REVISION WAS DONE WITH SIGMA FEMORAL SLEEVES AND TC3 FEMURS WITH A MBT REVISION TIBIA WITH SLEEVES ON BOTH THE RIGHT AND LEFT WITHOUT USING CEMENT. FEMUR ON RIGHT SIDE WAS UNSUPPORTED BY BONE AND HAD DEVELOPED METAL DEBRIS FROM THE ZERO BOLT AND SLEEVE ADAPTER. SURGEON REMOVED FEMUR AND REPLACED WITH A DISTAL FEMUR ON THE RIGHT SIDE. SLEEVES ON BOTH SIDES WERE WELL FIXED ON THE RIGHT SIDE. DOI: (B)(6) 2015, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10656255 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017 THE PATIENT UNDERGOES A REVISION RIGHT TOTAL KNEE REPLACEMENT TO A HINGED KNEE REPLACEMENT CONSTRUCT DUE TO FAILURE OF RIGHT TOTAL KNEE REPLACEMENT SECONDARY TO INSTABILITY AND POSTEROLATERAL CORNER DEFICIENCY. FEMORAL COMPONENT AND INSERT WERE REVISED AND DEPUY FEMORAL IMPLANT, AUGMENTS, AND TIBIAL INSERT WERE IMPLANTED. DOI: (B)(6) 2017; DOR: (B)(6) 2017; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9402092 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017 THE PATIENT UNDERGOES A REVISION RIGHT TOTAL KNEE REPLACEMENT TO A HINGED KNEE REPLACEMENT CONSTRUCT DUE TO FAILURE OF RIGHT TOTAL KNEE REPLACEMENT SECONDARY TO INSTABILITY AND POSTEROLATERAL CORNER DEFICIENCY. FEMORAL COMPONENT AND INSERT WERE REVISED AND DEPUY FEMORAL IMPLANT, AUGMENTS, AND TIBIAL INSERT WERE IMPLANTED. DOI: (B)(6) 2017; DOR: (B)(6) 2017; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9402084 ↗
• InjuryOct 11, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 7956933 ↗
• InjuryJun 26, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATED THAT THE PATIENT HAD PRIMARY TKA ON BOTH SIDES 2 YEARS AGO BUT HAS EXPERIENCED CHRONIC EFFUSIONS ON BOTH KNEES SINCE PRIMARY SURGERY. PATIENT RTKA WAS REVISED ON (B)(6) 2017. HE DID PERFECTLY WELL FOR 8 DAYS ON THE 9TH DAY HE EXPERIENCED ACUTE SWELLING AND APPARENT INFECTION. SURGEON ELECTED TO I&D WITH POLY EXCHANGE ON (B)(6) 2017. HE ELECTED TO REMOVE ALL IMPLANTS ON (B)(6) 2017 AND IMPLANT ANTIBIOTIC BEADS, SPACER AND LOOSELY CEMENTED PRIMARY CR ATTUNE FEMUR, LOOSELY CEMENTED PSRP INSERT WITH TOP POST REMOVED. SURGEON IS AWARE THIS IS OFF LABEL BUT FELT IT WAS THE BEST INTEREST OF THE PATIENT.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 6666525 ↗