P.F.C. SIGMA 96-0848Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295234210), received between May 8, 2019 and Jan 13, 2021 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OPERATIVE NOTES (B)(6) 2019 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO PAIN, LIMITED RANGE OF MOTION AND LOOSENING AND MISPOSITION OF THE FEMORAL COMPONENT. UPON ENTERING THE JOINT, THICKENED SYNOVIUM WAS ENCOUNTERED AND A SYNOVECTOMY WAS PERFORMED. THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE AT THE BONE TO CEMENT INTERFACE. IT WAS ALSO INDICATED THAT THE FEMORAL COMPONENT HAD BEEN PREVIOUSLY PLACED IN A STATE OF FLEXION MISPOSITION, THIS WAS ALSO CORRECT WITH IMPLANTATION OF A NEW FEMORAL COMPONENT IN PROPER POSITION. FEMORAL COMPONENT AND INSERT WERE REVISED. DEPUY PRODUCTS WERE IMPLANTED ALONG WITH COMPETITOR CEMENT. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2016 (PATELLA). DOI: (B)(6) 2018 (INSERT, TIBIAL AND FEMORAL COMPONENTS). DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Loss of Range of Motion; Pain; Synovitis

  MAUDE report 11166077 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OPERATIVE NOTES (B)(6) 2019 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO PAIN, LIMITED RANGE OF MOTION AND LOOSENING AND MISPOSITION OF THE FEMORAL COMPONENT. UPON ENTERING THE JOINT, THICKENED SYNOVIUM WAS ENCOUNTERED AND A SYNOVECTOMY WAS PERFORMED. THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE AT THE BONE TO CEMENT INTERFACE. IT WAS ALSO INDICATED THAT THE FEMORAL COMPONENT HAD BEEN PREVIOUSLY PLACED IN A STATE OF FLEXION MISPOSITION, THIS WAS ALSO CORRECT WITH IMPLANTATION OF A NEW FEMORAL COMPONENT IN PROPER POSITION. FEMORAL COMPONENT AND INSERT WERE REVISED. DEPUY PRODUCTS WERE IMPLANTED ALONG WITH COMPETITOR CEMENT. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2016 (PATELLA). DOI: (B)(6) 2018 (INSERT, TIBIAL AND FEMORAL COMPONENTS). DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: Loss of Range of Motion; Pain; Synovitis

  MAUDE report 11165987 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. UNKNOWN BONE CEMENT WAS USED. NO SURGICAL DELAY. DOI: NOT INDICATED/UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11142672 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY, SYNOVITIS, TIBIAL INSERT WEAR, AND TIBIAL TRAY MIGRATION AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN MANUFACTURER PRODUCTS WERE REVISED. DEPUY PRODUCTS WERE IMPLANTED DURING THE REVISION. IT IS NOTED, AT THE END OF THE PROCEDURE, THE SURGEON REPORTED AN INTRAOPERATIVE DISTAL FEMORAL FRACTURE EXTENDING ABOUT 10 CM PROXIMALLY. THE FRACTURE WAS TREATED WITH 4 CERCLAGE WIRES AND NOTED TO BE STABLE. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, INSTABILITY, SWELLING, AND INFECTION. THE TIBIAL INSERT WAS EXCHANGED AND THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT. ON (B)(6) 2020, 5-WEEK POST-OPERATIVE VISIT INDICATED SIGNIFICANT EFFUSION OF THE LEFT KNEE WITH MILD ERYTHEMA BUT NO OVERALL WARMTH. AFTER REVISION, THE PATIENT RECEIVED IV ANTIBIOTICS VIA A PICC LINE. THE PATIENT'S CRP WERE STILL ELEVATED COMPARED TO NORMAL, BUT WERE CONTINUING TO TREND DOWN. THIS PC CAPTURES THE EFFUSION AND IV ANTIBIOTICS ON (B)(6) 2020.

  Patient problems: Edema; Erythema; No Code Available

  MAUDE report 9748855 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY, SYNOVITIS, TIBIAL INSERT WEAR, AND TIBIAL TRAY MIGRATION AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN MANUFACTURER PRODUCTS WERE REVISED. DEPUY PRODUCTS WERE IMPLANTED DURING THE REVISION. IT IS NOTED, AT THE END OF THE PROCEDURE, THE SURGEON REPORTED AN INTRAOPERATIVE DISTAL FEMORAL FRACTURE EXTENDING ABOUT 10 CM PROXIMALLY. THE FRACTURE WAS TREATED WITH 4 CERCLAGE WIRES AND NOTED TO BE STABLE. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, INSTABILITY, SWELLING, AND INFECTION. THE TIBIAL INSERT WAS EXCHANGED AND THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT. ON (B)(6) 2020, 5-WEEK POST-OPERATIVE VISIT INDICATED SIGNIFICANT EFFUSION OF THE LEFT KNEE WITH MILD ERYTHEMA BUT NO OVRAL WARMTH. AFTER REVISION, THE PATIENT RECEIVED IV ANTIBIOTICS VIA A PICC LINE. THE PATIENT'S CRP WERE STILL ELEVATED COMPARED TO NORMAL, BUT WERE CONTINUING TO TREND DOWN. THIS PC CAPTURES THE EFFUSION AND IV ANTIBIOTICS ON (B)(6) 2020.

  Patient problems: Edema; Erythema; No Code Available

  MAUDE report 9748849 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY, SYNOVITIS, TIBIAL INSERT WEAR, AND TIBIAL TRAY MIGRATION AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN MANUFACTURER PRODUCTS WERE REVISED. DEPUY PRODUCTS WERE IMPLANTED DURING THE REVISION. IT IS NOTED, AT THE END OF THE PROCEDURE, THE SURGEON REPORTED AN INTRAOPERATIVE DISTAL FEMORAL FRACTURE EXTENDING ABOUT 10 CM PROXIMALLY. THE FRACTURE WAS TREATED WITH 4 CERCLAGE WIRES AND NOTED TO BE STABLE. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, INSTABILITY, SWELLING, AND INFECTION. THE TIBIAL INSERT WAS EXCHANGED AND THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT. ON (B)(6) 2020, 5-WEEK POST-OPERATIVE VISIT INDICATED SIGNIFICANT EFFUSION OF THE LEFT KNEE WITH MILD ERYTHEMA BUT NO OVERALL WARMTH. AFTER REVISION, THE PATIENT RECEIVED IV ANTIBIOTICS VIA A PICC LINE. THE PATIENT'S CRP WERE STILL ELEVATED COMPARED TO NORMAL, BUT WERE CONTINUING TO TREND DOWN. THIS PC CAPTURES THE INTRAOPERATIVE FEMUR FRACTURE ON (B)(6) 2014.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9748782 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY, SYNOVITIS, TIBIAL INSERT WEAR, AND TIBIAL TRAY MIGRATION AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN MANUFACTURER PRODUCTS WERE REVISED. DEPUY PRODUCTS WERE IMPLANTED DURING THE REVISION. IT IS NOTED, AT THE END OF THE PROCEDURE, THE SURGEON REPORTED AN INTRAOPERATIVE DISTAL FEMORAL FRACTURE EXTENDING ABOUT 10 CM PROXIMALLY. THE FRACTURE WAS TREATED WITH 4 CERCLAGE WIRES AND NOTED TO BE STABLE. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, INSTABILITY, SWELLING, AND INFECTION. THE TIBIAL INSERT WAS EXCHANGED AND THE SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT. ON (B)(6) 2020, 5-WEEK POST-OPERATIVE VISIT INDICATED SIGNIFICANT EFFUSION OF THE LEFT KNEE WITH MILD ERYTHEMA BUT NO OVRAL WARMTH. AFTER REVISION, THE PATIENT RECEIVED IV ANTIBIOTICS VIA A PICC LINE. THE PATIENT'S CRP WERE STILL ELEVATED COMPARED TO NORMAL, BUT WERE CONTINUING TO TREND DOWN. THIS PC CAPTURES THE INTRAOPERATIVE FEMUR FRACTURE ON (B)(6) 2014.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9748780 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BROKE HER DISTAL FEMUR DUE TO FALL. A DISTAL FEMUR WITH SLEEVE AND STEM WAS USED TO GAIN STABILITY. ORIGINAL IMPLANT DATE WAS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9701644 ↗
• MalfunctionMay 8, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT WHILE ASSEMBLING THE REVISION COMPONENT (PARTS LISTED BELOW) THE LATERAL POSTERIOR AUGMENT COMBO FAILED TO SCREW/LOCK INTO THE FEMORAL TC3 COMPONENT. AFTER MULTIPLE ATTEMPTS BY 2 EXPERIENCED PEOPLE, A SECOND AUGMENT WAS OPENED; THIS AUGMENT ALSO FAILED TO LOCK INTO THE FEMORAL COMPONENT. WITH BOTH PIECES, WHEN THEY ATTEMPTED TO TORQUE THE SCREW WITH THE TORQUE WRENCH, THE AUGMENTS LIFTED AWAY FROM THE FEMUR. BOTH THE SURGEON AND THE ASSISTANT (A FORMER DEPUY REP) ARE WELL VERSED IN ASSEMBLING THESE COMPONENTS. DISTAL AUGMENTS WERE PLACED PRIOR TO THE ATTEMPTED PLACEMENT OF THE POSTERIOR AUGMENTS AS IS CUSTOMARY. THE CONCLUSION WAS THAT THE THREADS IN THE FEMORAL COMPONENT WERE NOT RIGHT. ONE OF THE POSTERIOR AUGMENTS WAS SUBSEQUENTLY CEMENTED ONTO THE FEMUR AND THE ENTIRE COMPONENT WAS CEMENTED INTO THE PATIENT. ALL OTHER AUGMENTS 3 ADDITIONAL) WERE ASSEMBLED IN THE NORMAL FASHION. THE STEM ALSO WENT ON WITH NO ISSUES. THERE WAS A SURGICAL DELAY OF 15 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 8590538 ↗
• MalfunctionMay 8, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT WHILE ASSEMBLING THE REVISION COMPONENT (PARTS LISTED BELOW) THE LATERAL POSTERIOR AUGMENT COMBO FAILED TO SCREW/LOCK INTO THE FEMORAL TC3 COMPONENT. AFTER MULTIPLE ATTEMPTS BY 2 EXPERIENCED PEOPLE, A SECOND AUGMENT WAS OPENED; THIS AUGMENT ALSO FAILED TO LOCK INTO THE FEMORAL COMPONENT. WITH BOTH PIECES, WHEN THEY ATTEMPTED TO TORQUE THE SCREW WITH THE TORQUE WRENCH, THE AUGMENTS LIFTED AWAY FROM THE FEMUR. BOTH THE SURGEON AND THE ASSISTANT (A FORMER DEPUY REP) ARE WELL VERSED IN ASSEMBLING THESE COMPONENTS. DISTAL AUGMENTS WERE PLACED PRIOR TO THE ATTEMPTED PLACEMENT OF THE POSTERIOR AUGMENTS AS IS CUSTOMARY. THE CONCLUSION WAS THAT THE THREADS IN THE FEMORAL COMPONENT WERE NOT RIGHT. ONE OF THE POSTERIOR AUGMENTS WAS SUBSEQUENTLY CEMENTED ONTO THE FEMUR AND THE ENTIRE COMPONENT WAS CEMENTED INTO THE PATIENT. ALL OTHER AUGMENTS 3 ADDITIONAL) WERE ASSEMBLED IN THE NORMAL FASHION. THE STEM ALSO WENT ON WITH NO ISSUES. THERE WAS A SURGICAL DELAY OF 15 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 8590532 ↗