P.F.C. SIGMA 1581-24-112Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295064503), received between Jan 30, 2018 and Jun 16, 2025 — classified as 19 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED KNEE AS PER SURGEON. SURGEON RETAINED FEMUR, PATELLA, TIBIA. SURGEON DID IRRIGATION DEBRIDEMENT AND POLY EXCHANGE. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22212307 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PERFORMED AN I&D OF AN INFECTED KNEE. SURGEON REMOVED TIBIAL INSERT TO PERFORM WASHOUT AND IMPLANTED A FRESH LINER. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21312371 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED, DUE TO POSSIBLE INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2016; DOR: (B)(6) 2024; AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19633067 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 17240911 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: ON (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17227547 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS WASHED OUT AND POLY EXCHANGE FOR INFECTION. KNEE WAS DONE OVER 20 YRS AGO. THERE WAS NO SURGICAL DELAY. DOI: 20 YRS AGO, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16452708 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2013. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15312017 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. POLY WAS EXCHANGED. WASH OUT WAS COMPLETED. ORIGINAL IMPLANT DATE IS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14573423 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN IN HIS KNEE POST UPPER RESPIRATORY INFECTION. INCISION AND DRAINAGE WAS PERFORMED UNEVENTFULLY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2019; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 13386040 ↗
• MalfunctionOct 15, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IMPLANTS MISSING IN THE WHEN PLASTIC COVERING OPENED IN THE OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12641204 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION LEFT TOTAL KNEE REPLACEMENT. PRIMARY KNEE DONE 12 MONTHS AGO ON (B)(6) 2020 WITH PFC FIXED BEARING CONSTRUCT. NO DEPUY CEMENT WAS USED IN PRIMARY CASE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12470598 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12383878 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS POSSIBLE INFECTION. POLY EXCHANGE WAS DONE. NO LOOSENING AND NO DELAY IN SURGERY. DOI: (B)(6) 2021. DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 11725037 ↗
• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2020 DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10491281 ↗
• InjuryAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON TUESDAY, (B)(6) 2020. SURGEON PERFORMED A REVISION KNEE ARTHROPLASTY ON THE RIGHT KNEE OF A PATIENT. SURGEON HAD PERFORMED THE INDEX SURGERY ON THE RIGHT KNEE OF THE PATIENT IN 2011. SINCE THE INDEX SURGERY, PATIENT HAS COMPLAINED OF PAIN, SOME INSTABILITY, AND MILD EFFUSION. SURGEON ELECTED TO REVISE THE RIGHT KNEE ON (B)(6) 2020. UPON EXPOSURE TO THE JOINT SPACE SURGEON EXAMINED THE PATELLAR AND TIBIAL COMPONENT AND DETERMINED THEY WERE WELL FIXED AND ELECTED TO LEAVE THEM IMPLANTED. WITH MINIMAL MECHANICAL EFFORT, SURGEON WAS ABLE TO EXPLANT THE FEMORAL COMPONENT WHICH WAS GENERALLY CLEAN OF THE COMPETITOR CEMENT EXCEPT ON THE POSTERIOR CONDYLES WHERE CEMENT REMAINED ATTACHED. SURGEON THEN PREPARED THE REMAINING BONE TO ACCEPT A REVISION FEMORAL COMPONENT AND REIMPLANTED. NO INSTRUMENTS BROKE DURING THE PROCEDURE. THERE WERE NO DELAYS IN RELATION TO DEPUY. THERE WAS NO SUGGESTION THAT THE IMPLANTS DID NOT PERFORM AS EXPECTED. THERE WAS NO NOTICEABLE POLY WEAR.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 10454983 ↗
• InjuryJul 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTED KNEE. SURGEON REMOVED ALL COMPONENTS AND PUT IN CEMENT SPACER. DOI: (B)(6) 2019 DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10222637 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO FALL AND STRETCHED OUT LIGAMENTS. SURGEON ENDED UP REPLACING THE 4X12.5 STABILIZED INSERT WITH A 4X15 STABILIZED PLUS INSERT. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Fall; No Code Available

  MAUDE report 9849004 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PATELLA CREPITUS. OPEN SYNOVECTOMY PERFORMED. POLY EXCHANGE ALSO PERFORMED DUE TO MILD LAXITY. SURGEON COMMENTS ABOUT INCREASED PATELLA CREPITUS WITH SIGMA PS KNEE. DOI: (B)(6) 2018, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9741920 ↗
• InjuryOct 7, 2019Adverse 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 PERFORMED. DOI: (B)(6) 2019. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9162642 ↗
• MalfunctionAug 30, 2019Difficult to Insert; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use

  TOTAL KNEE REPLACEMENT: (B)(6) 2019. WHEN TIBIAL INSERT WAS INSERTED IT WAS NOTED BY SURGEON THAT IT FAILED TO ENGAGE. NO EXTREME FORCE USED. DR STATES THE POLY WAS DAMAGED AT THE FRONT FLAP LEFT SIDE REQUESTED A REPLACEMENT. ON LOOKING AT THE POLY NOTICED THE FRONT LEFT FLAP WAS BENT. IT HAS NOT BROKEN OFF BUT APPEARS TO HAVE A SLIGHT WOBBLE. HE STATES THIS HAS HAPPENED BEFORE. 5 MINUTES DELAY. ACTION TAKEN TO MANAGE : POLY REMOVED AND ANOTHER ONE PUT IN ITS PLACE.

  Patient problems: Not Applicable

  MAUDE report 8951121 ↗
• MalfunctionAug 30, 2019Difficult to Insert; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use

  TOTAL KNEE REPLACEMENT: (B)(6) 2019. WHEN TIBIAL INSERT WAS INSERTED IT WAS NOTED BY SURGEON THAT IT FAILED TO ENGAGE. NO EXTREME FORCE USED. DR STATES THE POLY WAS DAMAGED AT THE FRONT FLAP LEFT SIDE REQUESTED A REPLACEMENT. ON LOOKING AT THE POLY NOTICED THE FRONT LEFT FLAP WAS BENT. IT HAS NOT BROKEN OFF BUT APPEARS TO HAVE A SLIGHT WOBBLE. HE STATES THIS HAS HAPPENED BEFORE. 5 MINUTES DELAY. ACTION TAKEN TO MANAGE : POLY REMOVED AND ANOTHER ONE PUT IN ITS PLACE. MALE PATIENT INITIALS: (B)(6), DOB: (B)(6).

  Patient problems: No Code Available; Not Applicable

  MAUDE report 8951063 ↗
• InjuryJan 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. THE SURGEON DID AN I&D WITH A POY EXCHANGE. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7227113 ↗