P.F.C. SIGMA 96-0102Recalls & reported problems

Summary

The FDA's MAUDE database contains 319 adverse event reports that list this exact device (DI 10603295232629), received between Jul 17, 2017 and Apr 16, 2026 — classified as 1 death, 304 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (25 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 25 most recent of 319 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING OF THE PATELLA. COMPONENTS THAT WERE LOOSE: PATELLA. LOOSENING INTERFACE: CEMENT TO IMPLANT. CEMENT MANUFACTURER: DEPUY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24894554 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD KNEE DISCOMFORT. POLY WAS WORN POSTERIOR LATERAL. PATELLA AND POLY WERE EXCHANGED. POLY WENT FROM 5X10 TO 5X12.5. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Discomfort

  MAUDE report 24702077 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO KNEE PATELLA LOOSENING AT BONE TO CEMENT INTERFACE. THE SURGEON WANTED TO INCREASE THE THICKNESS OF THE POLYETHYLENE SPACER TO INCREASE STABILITY. THE PATELLA WAS REMOVED DUE TO MALTRACKING. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24068392 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AVN IN PATELLA AND PATELLA BONE FRAGMENTED. PATELLA IMPLANT WAS EXPLANTED. POLY WAS EXPLANTED (4X12.5) AND A 4X15 WAS IMPLANTED. DOI: (B)(6) 2018. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Notching; Necrosis

  MAUDE report 23888107 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTED KNEE. IMPLANTS WERE REMOVED AND CEMENT SPACER WAS IMPLANTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23423495 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION FOR PAIN & INSTABILITY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23393572 ↗
• InjuryAug 14, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF PFC DUE TO LYSIS AND INSTABILITY. WHEN THE KNEE WAS OPENED, THE POLYETHYLENE HAD SOME UNNATURAL WEAR AND SIGNS OF LYSIS. CR FEMUR, POLYETHYLENE AND FB BASE WERE REMOVED. MINIMAL BONE LOSS ON TIBIAL SIDE. SOME BONE LOSE ON FEMORAL SIDE WHICH BONE GRAFT WAS USED TO CORRECT. PT HAD MINIMAL SIGNS OF INFECTION SO PROCEEDED TO IMPLANT ATTUNE REVISION. GOOD STABILITY ATTAINED WITH STEMS AND SLEEVES BOTH SIDES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY.

  Patient problems: Joint Laxity; Osteolysis; Unspecified Infection

  MAUDE report 22803635 ↗
• InjuryJul 29, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE IMPLANT IS WORN THEREFORE UNABLE TO READ THE LOT NUMBER.

  Patient problems: Insufficient Information

  MAUDE report 22648002 ↗
• InjuryApr 2, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF PATELLA COMPONENT AND REPLACED WITH NEW PATELLA. DOI: UNKNOWN, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21757745 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY, REQUIRING EXTENSIVE DEBRIDEMENT. EXTENSIVE BONE EROSION WAS NOTED ON THE MEDIAL AND LATERAL FEMORAL CONDYLES AS WELL AS ALONG THE MEDIAL TIBIAL PLATEAU REQUIRING BONE GRAFTING TO CORRECT. GRANULATION TISSUE INDICATIVE OF LOOSENING WAS NOTED. THE FEMORAL AND TIBIAL SIDES WERE NOTED TO BE LOOSE - INTERFACE NOT IDENTIFIED. THE PATELLA WAS REMOVED AND UNDERNEATH SMALL CYSTS WERE IDENTIFIED AND REMOVED BEFORE REPLACING. A FRACTURE OF THE FEMORAL STEM AND THE CONNECTING SCREW OCCURRED WITHOUT TRAUMA. THE CONNECTING SCREW BETWEEN THE FEMORAL SHIELD AND THE FEMORAL SHAFT IS AFFECTED. THE REVISION WENT SMOOTHLY.

  Patient problems: Bone Notching; Cyst(s); Pocket Erosion; Unspecified Tissue Injury

  MAUDE report 21536927 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21345962 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. HE HAS SIGMA RP'S ON BOTH KNEES AND A SHOULDER REPLACEMENT AS WELL. ASPIRATION OF THE KNEE GREW C ACNES. PATIENT EXPERIENCING PAIN. SURGEON WAS REMOVING THE LEFT TKA TODAY AND REPLACING WITH A SPACER (ATTUNE CR FEMUR WITH ATTUNE CR RP INSERT CEMENTED INTO THE TIBIA). ACTIVITY LEVEL - YES. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 21253249 ↗
• InjuryJan 13, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT PATIENT FELL AND DAMAGED HER PATELLA IMPLANT. THE PATELLA APPEARED TO HAVE A DIVOT IN IT CAUSING THE SURGEON TO CHOOSE TO REVISE IT. A PATELLA AND POLY SWAP WAS PERFORMED. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: UNKNOWN.

  Patient problems: Fall

  MAUDE report 21139881 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT TOTAL KNEE JOINT EXPLANT DUE TO KNEE JOINT INFECTION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20577366 ↗
• InjuryOct 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT ORIGINAL SURGERY DATE, OPERATING SURGEON, AND LOCATION OF SURGERY WERE UNKNOWN. A RIGHT KNEE REVISION SURGERY OCCURRED ON (B)(6) 2024 DUE TO ANTERIOR KNEE PAIN. ONCE THE KNEE WAS OPENED, THE PATELLA WAS WARN OUT. THE SURGEON FELT THE PATIENT NEEDED THEIR PATELLA REVISED. THE PREVIOUS PATELLA WAS CUT OUT AND THE PATIENT WAS PREPARED FOR A THINNER PATELLA. THE REMAINING IMPLANTS FELT STABLE AND THERE WAS NO NEED TO REVISE. THE REAL PATELLA WAS OPENED AND IMPLANTED. STABILITY OF THE KNEE WAS CONFIRMED WHEN THE KNEE WAS RUN THROUGH A FULL RANGE OF MOTION. THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE.

  Patient problems: Pain

  MAUDE report 20536894 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENTS RECEIVED FOR RUPTURE OF HER PATELLAR TENDON REPAIR. NO IMPLANT OR EXPLANT DATES KNOWN. ISSUE OCCURRED ON RIGHT SIDE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20521114 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PFC IMPLANTS WERE REVISED DUE TO SUSPECTED LOOSENING AT TIBIAL SURFACE.

  Patient problems: Joint Laxity

  MAUDE report 20409627 ↗
• MalfunctionSep 16, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PATELLA CLUNK SYNDROME. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: POSSIBLY RELATED. DATE OF EVENT: 03 SEP 2024. DEVICE LOCATION: RIGHT. ADDITIONAL EVENT INFORMATION: PATELLA CLUNK IS AN EXTENSOR MECHANISM INJURY. AS SUCH, THE PRODUCTS THAT MAKE UP THIS MECHANISM ARE THE ARTICULATING SURFACES OF THE PATELLA AND FEMORAL COMPONENT.

  Patient problems: Insufficient Information; Pain; Unspecified Musculoskeletal problem

  MAUDE report 20225176 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ADHESIONS: IS THIS EVENT RELATED TO THE STUDY DEVICE? NOT RELATED. IS THIS EVENT RELATED TO THE STUDY PROCEDURE? REMOTE POSSIBILITY. DATE OF EVENT: 28/AUG/2024. ADDITIONAL EVENT INFORMATION: CLINIC NOTE ADDED: 5 SEP 2024. ON (B)(6) 2024, MEDICAL RECORDS NOTE, THE PATIENT IS FOUR YEARS POST RIGHT TOTAL KNEE ARTHROPLASTY. THE PATIENT WAS NOTED, TO HAVE ARTHROFIBROSIS KNEE WITH PAIN AND STIFFNESS. THE PATIENT HAD A SCAR TISSUE SURGERY WITH OPEN RESECTION, POLY SWAP IN THE PAST. THE PATIENT THEN FELL AND HAD REGRESSION AND RETURN OF ARTHROFIBROSIS. THE PATIENT HAS INCREASED PAIN, DIFFICULT TIME WITH MOBILITY. AN ASPIRATION OF KNEE WAS PERFORMED. AND NEGATIVE FOR ANY TIME OF BACTERIAL INFECTION. THE SURGEON SUGGESTED, TOTAL KNEE ARTHROPLASTY REVISION FOR ARTHROFIBROSIS.

  Patient problems: Adhesion(s); Fall; Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 20223288 ↗
• InjuryAug 28, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE POLY AND PATELLA WERE SWAPPED DUE TO POLY WEAR. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20086091 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR CHRONIC INFECTION, INFECTION - DEEP. DEVICE RELATED: REMOTE POSSIBILITY. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 17/JUL/2024. DATE OF IMPLANT: INFORMATION NOT PROVIDED. DATE OF REVISION: INFORMATION NOT PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INFORMATION NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 19906277 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. ASSOCIATED STUDY: ROTATING PLATFORM, ROTATING PLATFORM DATE OF EVALUATION: (B)(6) 2024. DATE OF ONSET: (B)(6) 2024 OPERATIVE SIDE: RIGHT. DIAGNOSIS: CHRONIC INFECTION. ADVERSE EVENT: INFECTION - DEEP. SPECIFY: COUNTRY: US. SERIOUS: YES. DEVICE RELATED: REMOTE POSSIBILITY. PROCEDURE RELATED: REMOTE POSSIBILITY. ADDITIONAL EVENT INFORMATION: ON (B)(6) 2021, THE PATIENT WAS NOTED TO HAVE HAD A RIGHT TOTAL KNEE ARTHROPLASTY. ON (B)(6) 2022, THE PATIENT WAS NOTED TO HAVE FALLEN AND SUSTAINED A DISTAL FEMUR FRACTURE AND UNDERWENT ORIF OF THE DISTAL FEMUR FRACTURE. ON (B)(6) 2024 MEDICAL RECORDS NOTE THE PATIENT HAD RIGHT KNEE PAIN, STATUS POST TOTAL KNEE REPLACEMENT AND SUBSEQUENT ORIF OF DISTAL FEMUR FRACTURE. IT WAS NOTED THAT THE PATIENT CONTINUES TO HAVE INTERMITTENT CELLULITIS SINCE THE ORIF ON (B)(6) 2022. IT WAS NOTE THAT THE PATIENT HAD INTERMITTENT CELLULITIS. THE KNEE HAD BE ASPIRATED (B)(6) 2023, WHICH SHOWED A STAPH EPIDERMIDIS INFECTION. RADIOLOGICAL REPORT NOTES THE PATIENT HAS A RIGHT TOTAL KNEE ARTHROPLASTY WITH SUBSIDENCE AND LOOSENING OF THE FEMORAL COMPONENT. THE RIGHT KNEE WAS NOTED TO HAVE CHRONIC INFECTION.

  Patient problems: Cellulitis; Pain; Unspecified Infection

  MAUDE report 19709645 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR PULMONARY EMBOLISMS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: ORAL MEDICATION AND CLOT REMOVALS.

  Patient problems: Pulmonary Embolism

  MAUDE report 19463156 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE WAS THE RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19447895 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR POSSIBLE INFECTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023 DATE OF EVENT: (B)(6) 2024 (LEFT KNEE) TREATMENT: ASPIRATION/DRAINAGE.

  Patient problems: Unspecified Infection

  MAUDE report 19231792 ↗