P.F.C. SIGMA 96-0900Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295234463), received between Sep 20, 2018 and Sep 11, 2023 — classified as 10 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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.

• InjurySep 11, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN. ONCE SURGEON FLEXED THE KNEE, THE FEMUR FELL OFF. THE FEMORAL ADAPTER BOLT BROKE. HAD TO REMOVE STEM & SLEEVE AND PUT IN A NEW STEM AND SLEEVE WITH A TC3 FEMUR. DOI: UNKNOWN DOR: (B)(6) 2023 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17718641 ↗
• InjurySep 11, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN. ONCE SURGEON FLEXED THE KNEE, THE FEMUR FELL OFF. THE FEMORAL ADAPTER BOLT BROKE. HAD TO REMOVE STEM & SLEEVE AND PUT IN A NEW STEM AND SLEEVE WITH A TC3 FEMUR. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17718634 ↗
• InjuryDec 8, 2021Noise, Audible; Noise, Audible

  THIS PC WAS CREATED TO CAPTURE THE EVENT HAPPENED ON (B)(6) 2013. ON (B)(6) 2013, THE PATIENT HAD A LEFT KNEE ARTHROSCOPIC SYNOVECTOMY TO ADDRESS LEFT KNEE ARTHROFIBROSIS AFTER TOTAL KNEE. THE INDICATIONS FOR SURGERY NOTED THAT THE PATIENT HAD A PREVIOUS TOTAL KNEE, AND THEN LATER ON REQUIRED A REVISION TO A TC-III STYLE IMPLANT BY DEPUY. THE PATIENT DEVELOPED CATCHING OF HIS KNEE, SWELLING, AND RECURRENT HEMARTHROSIS. DURING THIS CURRENT PROCEDURE THE SURGEON OBSERVED PERIPATELLAR ARTHROFIBROSIS. (PAGE 106 OF 274) NO COMPONENTS WERE REVISED. NO OTHER INFO WAS PROVIDED. DOI: (B)(6) 2011, DOE: (B)(6) 2013, LEFT KNEE.

  Patient problems: Adhesion(s); Hemorrhage/Blood Loss/Bleeding; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 12961886 ↗
• InjuryDec 8, 2021Noise, Audible; Noise, Audible

  THIS PC WAS CREATED TO CAPTURE THE EVENT HAPPENED ON (B)(6) 2013. ON (B)(6) 2013, THE PATIENT HAD A LEFT KNEE ARTHROSCOPIC SYNOVECTOMY TO ADDRESS LEFT KNEE ARTHROFIBROSIS AFTER TOTAL KNEE. THE INDICATIONS FOR SURGERY NOTED THAT THE PATIENT HAD A PREVIOUS TOTAL KNEE, AND THEN LATER ON REQUIRED A REVISION TO A TC-III STYLE IMPLANT BY DEPUY. THE PATIENT DEVELOPED CATCHING OF HIS KNEE, SWELLING, AND RECURRENT HEMARTHROSIS. DURING THIS CURRENT PROCEDURE THE SURGEON OBSERVED PERIPATELLAR ARTHROFIBROSIS. (PAGE 106 OF 274) NO COMPONENTS WERE REVISED. NO OTHER INFO WAS PROVIDED. DOI: (B)(6) 2011, DOE: (B)(6) 2013, LEFT KNEE.

  Patient problems: Adhesion(s); Hemorrhage/Blood Loss/Bleeding; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 12961823 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2017. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11455619 ↗
• InjuryOct 29, 2020Loss of Osseointegration; Loss of Osseointegration

  REVISION ON (B)(6) 2020 OF PREVIOUSLY REVISED KNEE TO TREAT BONE LOSS SECONDARY TO ASEPTIC FEMORAL IMPLANT LOOSENING. AN ATTUNE REVISION WAS USED TO REVISE A TC3. ORIGINAL REVISION SURGERY (TC3) WAS CONDUCTED ON (B)(6) 2009. REASON FOR RE-REVISION WAS FEMORAL LOOSENING (FEMUR + STEM CONSTRUCT). THE ORIGINAL MBT REVISION WAS STILL WELL FIXED SO DIDN'T REQUIRE REMOVAL/REPLACEMENT. TC3 FEMUR + STEM WAS REMOVED. INSERT WAS REMOVED. ATTUNE REVISION FEMUR, SLEEVE AND STEM IMPLANTED. ATTUNE REVISION CRS INSERT IMPLANTED INTO ORIGINAL MBT TRAY (NOT INDICATED).

  Patient problems: Inadequate Osseointegration; Injury; No Code Available

  MAUDE report 10758098 ↗
• InjuryOct 29, 2020Loss of Osseointegration; Loss of Osseointegration

  REVISION ON (B)(6) 2020 OF PREVIOUSLY REVISED KNEE TO TREAT BONE LOSS SECONDARY TO ASEPTIC FEMORAL IMPLANT LOOSENING. AN ATTUNE REVISION WAS USED TO REVISE A TC3. ORIGINAL REVISION SURGERY (TC3) WAS CONDUCTED ON (B)(6) 2009. REASON FOR RE-REVISION WAS FEMORAL LOOSENING (FEMUR + STEM CONSTRUCT). THE ORIGINAL MBT REVISION WAS STILL WELL FIXED SO DIDN'T REQUIRE REMOVAL/REPLACEMENT. TC3 FEMUR + STEM WAS REMOVED. INSERT WAS REMOVED. ATTUNE REVISION FEMUR, SLEEVE AND STEM IMPLANTED. ATTUNE REVISION CRS INSERT IMPLANTED INTO ORIGINAL MBT TRAY (NOT INDICATED).

  Patient problems: Inadequate Osseointegration; Injury; No Code Available

  MAUDE report 10758074 ↗
• InjuryJun 29, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2018, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10207465 ↗
• InjurySep 20, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND TIBIAL TRAY AND FEMORAL COMPONENT LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED IN THE PREVIOUS OPERATION. DOI: (B)(6) 2005 (STEM); DOI: (B)(6) 2007 (FEMORAL); DOR: (B)(6) 2009.

  Patient problems: Not Applicable; Pain

  MAUDE report 7895246 ↗
• InjurySep 20, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND TIBIAL TRAY AND FEMORAL COMPONENT LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED IN THE PREVIOUS OPERATION. DOI: (B)(6) 2005 (STEM). DOI: (B)(6) 2007 (FEMORAL). DOR: (B)(6) 2009.

  Patient problems: Not Applicable; Pain

  MAUDE report 7895220 ↗