P.F.C. SIGMA 96-2133Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295241263), received between Sep 14, 2017 and May 1, 2025 — classified as 23 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD LEFT KNEE REPLACED IN 2009. ACCORDING TO SURGEON, THE PATIENT DID WELL UNTIL THIS WEEK WHERE PATIENT FELL ILL AND CAME INTO THE ER. PATIENT'S KNEE WAS ASPIRATED AND SHOWED SIGNS OF INFECTION. A THOROUGH I&D WAS DONE WITH A POLY EXCHANGE. THE FEMUR, TIBIAL COMPONENT, AND PATELLA WERE LEFT IN SITU. DOI: (B)(6) 2009. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 21945529 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INFECTION. SURGEON WASHED OUT THE KNEE AND SWAPPED POLY. NO LOOSENING PRESENT. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19088214 ↗
• InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO I&D POLY EXCHANGE FOR INFECTION. INCREASED WHITE COUNT, CULTURES NOT BACK YET. NO SURGICAL DELAY WAS THERE. DOI: 2008, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16619131 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL UNSTABLE KNEE. THE TIBIA WAS LOOSE DUE TO NO CEMENT BEING ON THE IMPLANT. THE FEMUR WAS LOOSE DUE TO NO CEMENT BEING ON THE BONE. CEMENT MANUFACTURER WAS UNKNOWN. THERE WAS NO SURGICAL DELAY. REP COULD NOT SEE NUMBERS ON THE FEMUR. SIZE WAS OBTAINED FROM THE ORIGINAL OP NOTE. A POLY EXCHANGE WAS DONE ON (B)(6) 2018. DOI: (B)(6) 2006. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16324828 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN UNSTABLE KNEE. TIBIAL AND PATELLA REVISION WERE PERFORMED. PATELLA PRODUCT AND LOT NUMBERS COULD NOT BE DISCERNED ON THE EXPLANT. SIGMA PS FEMUR REMAINS INSITU (PRODUCT AND LOT NUMBERS ARE UNKNOWN). DOI: (B)(6) 2011. DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14828702 ↗
• InjuryMay 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO KNEE INSTABILITY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14353941 ↗
• InjuryMar 31, 2022Naturally Worn; Naturally Worn

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT KNEE TO ADDRESS POLYETHYLENE WEAR DATE OF IMPLANTATION: (B)(6) 2002. DATE OF REVISION: (B)(6) 2022. (LEFT KNEE). TREATMENT: REVISION OF TIBIAL INSERT AND PATELLA COMPONENTS. PRODUCT DETAILS: CATALOG: 129434130. LOT: V49AS1003. DESCRIPTION: MBT POROCOAT KEEL SZ 3.

  Patient problems: Insufficient Information; Pain; Synovitis

  MAUDE report 13965324 ↗
• InjuryJan 18, 2022Noise, Audible; Noise, Audible

  THE PATIENT WAS REVISED DUE TO CLICKING SOUND IN THE KNEE GOING FROM FLEXION TO EXTENSION. SOME BONE AND SOFT TISSUE WERE REMOVED. DOI: (B)(6) 2015; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

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

  MAUDE report 13280145 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND HETEROTOPIC BONE FORMATION. DOI: UNKNOWN; DOR: (B)(6) 2021; (RIGHT KNEE).

  Patient problems: Extraskeletal ossification; Pain

  MAUDE report 12480967 ↗
• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. I&D AND POLY EXCHANGE WERE DONE. DOI: UNKNOWN. DOR: (B)(6) 2021. LEFT KNEE.

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

  MAUDE report 11984698 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS AN OPENED INCISION DUE TO FALL. I&D AND POLY EXCHANGE PERFORMED. NO LOOSENING AND NO DELAY TO SURGERY REPORTED. DOI: (B)(6) 2020; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 11327788 ↗
• InjuryDec 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2011; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11077163 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON PERFORMED POLYETHYLENE EXCHANGE DUE TO PATIENT LIGAMENT INSTABILITY. FEMUR AND TIBIAL COMPONENT WERE WELL FIXATED AND NOT CHANGED. WE WERE UNABLE TO FIND ANY PRODUCT INFORMATION ON THE REMOVED POLY, THERE WERE NO STICKERS ON ANY RECORDS AND THE CODES ON THE POLY WERE UNREADABLE. THE INFORMATION WE DO HAVE IS THAT IT WAS A TIBIAL INSERT ROTATING PLATFORM, STABILIZED, SIZE 3, 15MM.

  Patient problems: No Code Available

  MAUDE report 10562765 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT A STAGE 1 OF A 2-STAGE REVISION WITH THE IMPLANTATION OF A TEMPORARY ANTIBIOTIC CEMENT SPACER AND ANTIBIOTIC BEADS, AND DEBRIDEMENT, DUE TO INFECTION, INFLAMMATION, AND CELLULITIS. HE NOTED UNHEALTHY LOOKING AND ALMOST PURULENT LOOKING TISSUE WHICH WAS CULTURED AND DEBRIDED. THE SURGEON REPORTED THE REMOVAL OF THE TIBIAL AND FEMORAL COMPONENTS, THE REVISION OF THE PATELLAR COMPONENT, AND THE IMPLANTATION OF THE ANTIBIOTIC SPACER AND ANTIBIOTIC BEADS. THE SURGEON REPORTED PARTIAL AVULSION OF THE PATELLAR TENDON AS A COMPLICATION. THE PATIENT WAS IMPLANTED WITH COMPETITOR SPACER AND SMARTSET BONE CEMENT X 2. DOI: (B)(6) 2015: (PATELLAR COMPONENT AND 2 BONE CEMENT). DOI: (B)(6) 2018 (TIBIAL TRAY, INSERT, STEM AND FEMORAL COMPONENT). DOR: (B)(6) 2018 (RT KNEE).

  Patient problems: Cellulitis; Inflammation; No Code Available; Unspecified Infection

  MAUDE report 9418176 ↗
• InjuryNov 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION AFTER HAVING A TKA. THE PATIENT WAS TAKEN BACK TO THE OR FOR A POLY SWAP. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9371785 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED SO SHE GOT WASHED OUT AND HER POLY WAS REPLACED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9361696 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. POLY SWAP WAS DONE. THE POLY WAS DOWNSIZED AND CONSTRAINED DUE TO SOFT TISSUE LAXITY. THE MBT REVISION TIBIA AND TC3 FEMORAL COMPONENTS WERE LEFT UNTOUCHED. DOI: UNK; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8655356 ↗
• InjuryApr 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A POLY INSERT EXCHANGE AND SYNOVECTOMY FOR FAILED LEFT TKA FOR PAIN, DISABILITY, AND INABILITY TO FULLY EXTEND KNEE.

  Patient problems: Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8544805 ↗
• InjuryApr 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE 03 JAN 2019: ON (B)(6) 2014, 3 DAYS AFTER LEFT TKA REVISION, PATIENT DEVELOPED PULMONARY EDEMA AND CONGESTIVE HEART FAILURE WITH POSSIBLE MI. HE UNDERWENT A CABG X 5 FOR 3 VESSEL CARDIAC DISEASE ON (B)(6) 2014. PATIENT DEVELOPED BILATERAL PLEURAL EFFUSIONS AND INFECTION AFTER CABG REQUIRING STERNAL WOUND VAC AND IV ANTIBIOTIC ON (B)(6) 2014. DOI: (B)(6) 2014.

  Patient problems: Heart Failure; Myocardial Infarction; Pleural Effusion; Pulmonary Edema; Unspecified Infection

  MAUDE report 8539776 ↗
• InjuryApr 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE 03 JAN 2019: ON (B)(6) 2014, THE PATIENT UNDERWENT LEFT ARTHROSCOPY AND DEBRIDEMENT FOR EXCESSIVE SCARRING, PAIN AND DECREASED ROM TO THE LEFT KNEE. DOI: (B)(6) 2013, DOE: (B)(6) 2014.

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

  MAUDE report 8539346 ↗
• InjuryJun 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION, OSTEOLYSIS AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT AT BONE TO CEMENT INTERFACE. CEMENT MANUFACTURING IS UNKNOWN. DOI: (B)(6) 2013 FOR THE TIBIA, FEMUR AND PATELLA. DOI: (B)(6) 2013 FOR THE INSERT. DOR: (B)(6) 2018. LEFT KNEE.

  Patient problems: Not Applicable; Osteolysis; Unspecified Infection

  MAUDE report 7613598 ↗
• InjuryApr 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. POLY SWAP. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7421855 ↗
• InjurySep 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS BEHIND THE FEMORAL COMPONENT AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN.

  Patient problems: Osteolysis

  MAUDE report 6866304 ↗