P.F.C. SIGMA 96-0110Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295232650), received between Jul 24, 2017 and May 5, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO ANTERIOR KNEE PAIN. DOI: ON (B)(6) 2017, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT.

  Patient problems: Pain

  MAUDE report 25084202 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF INSTABILITY IN THE KNEE POST TKA. THE PATIENT HAD A FALL AND SUFFERED A FEMUR FRACTURE WHICH WAS FIXED WITH A RETROGRADE NAIL AND SCREWS. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 21345595 ↗
• InjuryFeb 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED LEFT TOTAL KNEE. IMPLANTED DFR ON (B)(6) 2023 AND A POLY EXCHANGE ON (B)(6) 2023. PATIENT CAME INFECTED SO THEY EXPLANTED ALL IMPLANTS AND IMPLANTED A CEMENT SPACER USING ANTIBIOTIC SPACER AND EX-FIX RODS AND CONNECTOR. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 18774991 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S PRIMARY KNEE COMPONENTS WERE EXPLANTED (REMOVED) DUE TO INFECTION. THEY WERE REPLACED BY A TEMPORARY ANTIBIOTIC STATIC SPACER. DOI: (B)(6) 2018, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14698623 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. NO LOOSENING REPORTED. DOI: (B)(6) 2020; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12719472 ↗
• InjuryJul 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON REMOVED ALL COMPONENTS AND PUT IN SPACERS. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10271855 ↗
• InjuryJun 24, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE PATIENT WAS REVISED DUE TO A TIGHT KNEE. IT WAS REPORTED THAT THE SURGEON HAD CUT THE PATELLA WRONG. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 10191886 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. ALL IMPLANTS WERE REMOVED. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9009760 ↗
• InjuryAug 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN, POSSIBLE INFECTION. CULTURES WAS OUT CLEAN AND SURGEON REVISED TO A TC3 KNEE REVISION. DOI: UNKNOWN; DOR: (B)() 2018; LEFT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7790845 ↗
• InjuryJan 8, 2018Noise, Audible; Noise, Audible

  THE PATIENT WAS REVISED TO ADDRESS FOR PATELLA CLUNK SYMPTOMS. PATELLA AND INSERT REPLACED. DOI: UNKNOWN. DOR: (B)(6). UNKNOWN AFFECTED SIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7171397 ↗
• InjuryOct 26, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE UNKNOWN COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 6980044 ↗
• InjuryOct 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE UNKNOWN COMPONENT AT BONE TO CEMENT INTERFACE, CEMENT MANUFACTURER IS UNKNOWN. THE IMPLANTS WERE LOOSE BECAUSE OF INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6977738 ↗
• InjuryJul 24, 2017Noise, Audible; Noise, Audible

  PATIENT WAS REVISED TO ADDRESS PATELLAR CLUNK.

  Patient problems: No Information

  MAUDE report 6736027 ↗