P.F.C. SIGMA 96-2132Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10603295241256), received between Aug 29, 2017 and May 4, 2026 — classified as 46 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 46 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BILATERAL KNEE INFECTIONS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25066481 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO BILATERAL KNEE INFECTIONS. NO ADVERSE CONSEQUENCES. THE IMPLANTATION DATE IS UNKNOWN. OVER 20 YEARS AGO. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24945221 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION AND UNDERWENT I&D POLY X. NO ADDITIONAL INFORMATION IS AVAILABLE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23346757 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE HAS BEEN TOO TIGHT SINCE THE 12.5 POLY WENT IN. SURGEON PULLED IT OUT AND PUT IN A 10MM FOR MORE RANGE OF MOTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 22174852 ↗
• InjuryFeb 19, 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 A PAINFUL KNEE. SURGEON EXCHANGED THE POLY AND PATELLA. THE ORIGINAL DATE OF SURGERY WAS 2007. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21413960 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING INCREASING ANTERIOR KNEE PAIN AND INSTABILITY. FEMORAL REVISION PERFORMED. NO SURGICAL DELAY, NO ADVERSE CONSEQUENCES FOR THE PATIENT. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21061350 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: INCISION AND DRAINAGE LEFT TOTAL KNEE REPLACEMENT WITH REMOVAL OF ALL IMPLANTS INCLUDING FEMORAL, TIBIAL, AND PATELLAR COMPONENTS AND ALL CEMENT AND PLACEMENT WITH AN ARTICULATING SPACER. IV ANTIBIOTIC IS CONTINUOUS FOR 4 WEEKS. AN UNKNOWN FEMORAL COMPONENT, TIBIAL TRAY, AND PATELLA WILL BE ADDED AS THIS IS NEW INFORMATION RECEIVED.

  Patient problems: Unspecified Infection

  MAUDE report 20506692 ↗
• InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS AND OPERATIVE NOTES WERE RECEIVED. ON (B)(6) 2007, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY. DEPUY PRODUCTS, INCLUDING, TIBIAL TRAY, INSERT, FEMORAL COMPONENT, PATELLA, AND CEMENT X1 WERE UTILIZED DURING THIS PROCEDURE. NO PART-SPECIFIC PART NUMBER WAS PROVIDED FOR THE CEMENT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19288672 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 19133885 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED, DUE TO INSTABILITY. THE PATELLA HAS BEEN REVISED AND POLY EXCHANGE PERFORMED. DOI: (B)(6) 2008, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18852640 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18209208 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT HAD REVISION SIGMA COMPONENTS CURRENTLY IMPLANTED BUT THE TIBIAL COMPONENT HAD FALLEN INTO VARUS AND THE TIBIAL STEM WAS PROTRUDING OUT OF THE LATERAL CORTEX OF THE TIBIA. THIS PATIENT ALSO HAD STABILITY ISSUES SO SURGEON REMOVED BOTH THE TIBIAL AND FEMORAL COMPONENTS AND REPLACED THEM WITH AN ATTUNE REVISION TIBIAL TRAY, STEM, AND SLEEVE. DOI: UNKNOWN, DOR: ON (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17443712 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO MULTIPLE FALLS AND AN ELEVATED BMI. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2010 DOR- (B)(6) 2023. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Fall

  MAUDE report 16760881 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INSTABILITY. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15794392 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO STAPHYLOCOQUE INFECTION. DOI: (B)(6) 2020; DOR: (B)(6) 2022; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15502576 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON PERFORMED A TOTAL KNEE REPLACEMENT ON HER RT KNEE IN 2011. UNTIL NOW, THE PATIENT HAS HAD NO PROBLEMS WITH HER KNEE. THE PATIENT HAS BEEN ADMITTED TO HOSPITAL FOR SEVERAL WEEKS WITH GI ISSUES. UPON EXAM, THE SURGEON ASPIRATED THE PT¿S KNEE AND DETERMINED IT TO BE INFECTED. A SURGICAL I & D AND A POLY EXCHANGE WAS PERFORMED. DURING SURGERY, IT WAS DETERMINED THAT ALL COMPONENTS WERE WELL FIXED. A SZ 3 12.5 INSERT WAS PLACED AND THE KNEE WAS STABLE AND A FULL RANGE OF MOTION WAS ACHIEVED. NO FURTHER INFORMATION IS AVAILABLE DOI: 2011. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 15216368 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FEMORAL COMPONENT WAS REVISED DUE TO PAIN. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 13903903 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 13343100 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE BECAME INFECTED AND THE IMPLANT WAS REMOVED. THE LOT NUMBER WAS NOT PROVIDED AND UNABLE TO LOCATE PAST RECORDS. DOI: 2013. DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13334164 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2021 , (RIGHT KNEE).

  Patient problems: Pain

  MAUDE report 13167622 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI : UNKNOWN, DOR : (B)(6) 2021, RIGHT SIDE.

  Patient problems: Pain

  MAUDE report 13095044 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STIFFNESS. PATIENT WAS ONLY ABLE TO EXTEND HER KNEE APPROXIMATELY SEVENTY DEGREES, ACCORDING TO THE SURGEON WHO PERFORMED THIS PATIENT'S PRIMARY AND REVISION PROCEDURE. THE PATIENT'S PRIMARY SIGMA COMPONENTS WERE REMOVED AND REPLACED BY ATTUNE REVISION COMPONENTS. DOI: (B)(6) 2008; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 12373265 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL RIGHT KNEE. DEBRIDEMENT AND POLY EXCHANGE WAS DONE. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12294868 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL LEFT KNEE. NO LOOSENING REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6). LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11832856 ↗
• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. POLY WAS EXCHANGED WAS DONE. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11338199 ↗