P.F.C. SIGMA 96-0881Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295234371), received between Nov 3, 2017 and Nov 13, 2025 — classified as 21 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (8 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD DEVELOPED PAINFUL LAXITY OVER TIME. THE COMPONENTS APPEARED TO BE WELL FIXED. A REVISION KNEE WAS SCHEDULED TO ADDRESS LAXITY. DURING THE OPERATION, IT WAS NOTED THAT THERE WAS METAL DEBRIS BEING GENERATED BY THE PROSTHESIS AS THERE WAS STAINING THROUGHOUT THE CAPSULE. THE FEMORAL COMPONENT WAS REMOVED, AND IT APPEARED THAT THE DEBRIS WAS BEING GENERATED AT THE TAPER BETWEEN THE FEMORAL ADAPTER AND THE FEMORAL SLEEVE; BOTH OF WHICH WERE WELL FIXED. THE WELL-FIXED TIBIAL TRAY WAS REMOVED. TRIALS WERE PLACED AND MOTION AND STABILITY WAS CONFIRMED. FINAL COMPONENTS WERE PLACED. NO PATIENT HARM NOR DELAY WAS NOTED. PATIENT APPEARED HAVE HAD THICKER INSERTS PLACED ON (B)(6) 2020 AND (B)(6) 2021. DOI: (B)(6) 2017. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23543394 ↗
• InjuryJul 11, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL COMPONENT WAS DUE TO BONE LOSS. CONVERTED TO A DFR. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Notching

  MAUDE report 22484547 ↗
• InjuryJul 11, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL COMPONENT WAS DUE TO BONE LOSS. CONVERTED TO A DFR. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Notching

  MAUDE report 22484515 ↗
• InjuryApr 23, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POSSIBLE ASEPTIC LOOSENING. REMOVED ALL IMPLANTS AND CONVERTED TO ATTUNE REVISION KNEE IMPLANTS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21893442 ↗
• InjuryApr 23, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POSSIBLE ASEPTIC LOOSENING. REMOVED ALL IMPLANTS AND CONVERTED TO ATTUNE REVISION KNEE IMPLANTS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21893436 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD LOSS OF MOBILITY DUE TO SUSPECTED HETEROTOPIC OSSIFICATION. THE PATIENT HAD A DEPUY TC3 RP REVISION KNEE. THE SZ 4 TC3 RIGHT FEMUR, 5 DEGREE BOLT, +2/-2 FEMORAL ADAPTOR, TC3 SZ 4 X 4 DISTAL AUGMENTS X2, TC3 SZ 4 X 4 POSTERIOR AUGMENT, 115 X 16 STEM AND TC3 RP SZ 4 X 12.5 INSERT WERE EXPLANTED. DOI: (B)(6) 2016, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Extraskeletal ossification; Loss of Range of Motion

  MAUDE report 20645450 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD LOSS OF MOBILITY DUE TO SUSPECTED HETEROTOPIC OSSIFICATION. THE PATIENT HAD A DEPUY TC3 RP REVISION KNEE. THE SZ 4 TC3 RIGHT FEMUR, 5 DEGREE BOLT, +2/-2 FEMORAL ADAPTOR, TC3 SZ 4 X 4 DISTAL AUGMENTS X2, TC3 SZ 4 X 4 POSTERIOR AUGMENT, 115 X 16 STEM AND TC3 RP SZ 4 X 12.5 INSERT WERE EXPLANTED. DOI: (B)(6) 2016. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Extraskeletal ossification; Loss of Range of Motion

  MAUDE report 20645437 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO NICKEL ALLERGY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18569666 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO NICKEL ALLERGY. DOI: UNKNOWN . DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18569599 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAINFUL RIGHT KNEE. DOI: (B)(4) 2016. DOR: (B)(4) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15586762 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL IMPLANT EXPLANTED, CONVERT TO ANTIBIOTIC SPACER DUE TO INFECTION. POLY INSERT CHANGED ON (B)(6) 2019 FROM PREVIOUS INFECTION. DOI: (B)(6) 2019 ALL EXPLANTED PRODUCTS, DOI: (B)(6) 2019 TIBIAL INSERT, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11917901 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL IMPLANT EXPLANTED, CONVERT TO ANTIBIOTIC SPACER DUE TO INFECTION. POLY INSERT CHANGED ON (B)(6) 2019 FROM PREVIOUS INFECTION. DOI: (B)(6) 2019 ALL EXPLANTED PRODUCTS, DOI: (B)(6) 2019 TIBIAL INSERT, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11917894 ↗
• InjuryApr 19, 2021Adverse 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 TOTAL REVISION DUE TO MULTIPLE ISSUES INVOLVING AN UNKNOWN MANUFACTURER KNEE SYSTEM. DEPUY PRODUCTS AND CEMENT WERE USED DURING THE OPERATION. THE SURGEON NOTED WHILE IMPLANTING THE TIBIAL COMPONENT THE CREATION OF A SMALL CRACK ANTERIOR MEDIAL IN THE TIBIA. IT WAS LESS THAN A MILLIMETER. IT WAS EXTREMELY STABLE AND DID NOT REQUIRE FIXATION OR INTERVENTION. ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT KNEE REVISION WITH REMOVAL OF RIGHT TOTAL KNEE IMPLANTS, ALL COMPONENTS, COMPLETE SYNOVECTOMY AND AGGRESSIVE DEBRIDEMENT, AND PLACEMENT OF TEMPORARY ANTIBIOTIC LOADED SPACER CONTAINING GENTAMICIN AND VANCOMYCIN ANTIBIOTIC TO ADDRESS RECURRENT INFECTION. THE SURGEON NOTED THE REMOVAL OF FIBROUS TISSUE. IT IS NOTED THE PATIENT ALSO HAD A LEFT KNEE ARTHROPLASTY OF UNKNOWN MANUFACTURER PRODUCTS PLACED IN 2014 WITH NO ISSUES.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11691204 ↗
• InjuryApr 19, 2021Adverse 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 TOTAL REVISION DUE TO MULTIPLE ISSUES INVOLVING AN UNKNOWN MANUFACTURER KNEE SYSTEM. DEPUY PRODUCTS AND CEMENT WERE USED DURING THE OPERATION. THE SURGEON NOTED WHILE IMPLANTING THE TIBIAL COMPONENT THE CREATION OF A SMALL CRACK ANTERIOR MEDIAL IN THE TIBIA. IT WAS LESS THAN A MILLIMETER. IT WAS EXTREMELY STABLE AND DID NOT REQUIRE FIXATION OR INTERVENTION. ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT KNEE REVISION WITH REMOVAL OF RIGHT TOTAL KNEE IMPLANTS, ALL COMPONENTS, COMPLETE SYNOVECTOMY AND AGGRESSIVE DEBRIDEMENT, AND PLACEMENT OF TEMPORARY ANTIBIOTIC LOADED SPACER CONTAINING GENTAMICIN AND VANCOMYCIN ANTIBIOTIC TO ADDRESS RECURRENT INFECTION. THE SURGEON NOTED THE REMOVAL OF FIBROUS TISSUE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11687732 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED FOR AN EVALUATION DUE TO RIGHT KNEE PAIN, SWELLING, SYNOVITIS, AND WARMTH. THE PHYSICIAN NOTED THE ASPIRATION OF 10 ML OF CLOUDY SLIGHTLY BROWNISH FLUID. THE PHYSICIAN INDICATED THE FLUID WOULD BE SENT OFF FOR CULTURES AND CELL COUNT. IT WAS ALSO NOTED THE PATIENT WOULD HAVE BLOOD WORK COMPLETED. THE PHYSICIAN INDICATED THE PATIENT WAS ON ORAL SUPPRESSION WITH DOXYCYCLINE.

  Patient problems: Pain; Swelling/ Edema; Synovitis

  MAUDE report 11516607 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED FOR AN EVALUATION DUE TO RIGHT KNEE PAIN, SWELLING, SYNOVITIS, AND WARMTH. THE PHYSICIAN NOTED THE ASPIRATION OF 10 ML OF CLOUDY SLIGHTLY BROWNISH FLUID. THE PHYSICIAN INDICATED THE FLUID WOULD BE SENT OFF FOR CULTURES AND CELL COUNT. IT WAS ALSO NOTED THE PATIENT WOULD HAVE BLOOD WORK COMPLETED. THE PHYSICIAN INDICATED THE PATIENT WAS ON ORAL SUPPRESSION WITH DOXYCYCLINE.

  Patient problems: Pain; Swelling/ Edema; Synovitis

  MAUDE report 11516592 ↗
• InjuryNov 22, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT MANUFACTURER WAS USED. UPON REVIEW OF X-RAYS DOCTOR DETERMINED THAT THE FEMORAL AND TIBIAL COMPONENTS LOOKED LOOSE. DOI: UNKNOWN; DOR: (B)(6) 2019 RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9364966 ↗
• InjuryNov 22, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT MANUFACTURER WAS USED. UPON REVIEW OF X-RAYS DOCTOR DETERMINED THAT THE FEMORAL AND TIBIAL COMPONENTS LOOKED LOOSE. DOI: UNKNOWN, DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9364959 ↗
• InjurySep 16, 2019Loss of or Failure to Bond; Malposition of Device; Migration; Loss of or Failure to Bond; Malposition of Device; Migration

  CLINIC NOTE DATED (B)(6) 2016, THE PATIENT PRESENTED FOR BILATERAL KNEE EVALUATIONS. IN THE RIGHT KNEE, THE PATIENT WAS EXPERIENCING PAIN AND SWELLING THAT DISSIPATES THROUGH THE DAY. PHYSICAL EXAM REVEALS RIGHT KNEE LAXITY. X-RAYS SUGGEST THE TIBIAL TRAY IS LOOSENING AND HAS SUBSIDED AS WELL AS POSSIBLE LOOSENING OF THE FEMORAL COMPONENT. THE SURGEON FEELS THE JOINT IS ADEQUATELY STABLE AND WILL CONTINUE TO MONITOR. THIS CLINIC NOTE IS CAPTURED ON (B)(4). (THIS PC CAPTURES THE PATIENT¿S FIRST NOTIFICATION OF COMPLAINTS REGARDING THE DEPUY REVISION PRODUCTS. NO INTERVENTION WAS PERFORMED, AND NO TREATMENT PROVIDED.) CLINIC NOTE DATED (B)(6) 2017: PATIENT PRESENTS FOR SCHEDULED FOLLOW-UP STATUS POST RIGHT KNEE REVISION. PATIENT REPORTS PAIN WITH AMBULATION THAT DISSIPATES THROUGH THE DAY. PHYSICAL EXAM REVEALS THE RIGHT LEG IS 15 MM SHORT, UNCHANGED LAXITY, AND POSITIVE DRAWER SIGN. X-RAY EXAMS REMAIN UNCHANGED WITH SIGNS TO TIBIAL TRAY LOOSENING AND SUBSIDENCE. THE SURGEON FEELS THE KNEE IS STABLE AND WILL CONTINUE TO MONITOR. THIS CLINIC NOTE IS CAPTURED ON (B)(4). CLINIC NOTE DATED (B)(6) 2018: PATIENT PRESENTS WITH PAIN THAT DISSIPATES THROUGH THE DAY. PHYSICAL EXAM IDENTIFIES T

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); No Code Available; Pain; Swelling; Synovitis

  MAUDE report 9071569 ↗
• InjuryOct 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY.

  Patient problems: No Code Available; Pain

  MAUDE report 7985980 ↗
• InjuryNov 3, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN, INSTABILITY AND LOOSENING OF THE FEMUR AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT IS USED.

  Patient problems: Pain

  MAUDE report 6999794 ↗