P.F.C. SIGMA 1581-22-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295064176), received between Nov 17, 2017 and Apr 21, 2026 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24945310 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16458942 ↗
• MalfunctionNov 7, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INSERT WOULD NOT FULLY ENGAGE IN TIBIAL TRAY OPENED A NEW ONE AND IT ENGAGED - BROKEN WHITE LEGO - BROKEN TIBIAL INSERT TRIAL. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15749592 ↗
• InjuryNov 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE WOUND WAS DRAINING, IRRIGATION AND DEBRIDEMENT. THERE WAS NO SURGICAL DELAY. NO OTHER INFORMATION WAS PROVIDED. DOI : (B)(6) 2021, DOR : (B)(6) 2021, RIGHT SIDE.

  Patient problems: Fluid Discharge

  MAUDE report 12836286 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS PAIN. SURGEON THOUGHT THERE WAS A FLEXION EXTENSION MISMATCH. DOI: UNKNOWN. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12616766 ↗
• InjuryAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. FAILED RIGHT TOTAL KNEE. DOI: (B)(6) 2017, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12316043 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF KNEE RESULTING IN A POLY INSERT SWAP. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2021 UNKNOWN KNEE SIDE

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

  MAUDE report 12123098 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL OF TOTAL JOINT AND PLACEMENT OF ANTIBIOTIC SPACER DUE TO INFECTION. LOOSENING REPORTED ON THE FEMORAL COMPONENT AT BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER NOT PROVIDED. DOI: (B)(6) 2015, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11614348 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT KNEE REVISION - ORIGINAL SURGERY (B)(6) 2016. REMOVED FEMUR, TRAY & INSERT DUE TO INSTABILITY AND PAIN. LOOSENING IMPLANT TO CEMENT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 10963186 ↗
• InjuryApr 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFLAMMATION, PAIN AND INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT KNEE.

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

  MAUDE report 10011454 ↗
• InjuryAug 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ABNORMAL COAGULATION FUNCTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF EVENT: (B)(6) 2019, (LEFT KNEE). ABNORMAL COAGULATION FUNCTION- ON (B)(6) 2019, THE PATIENT RETURNED TO THE HOSPITAL FOR VISIT 6. AFTER BLOOD COAGULATION EXAMINATION, THE APTT WAS 18.9S AND REPORTED AS A RISK VALUE. THE IT WAS JUDGED AS CS BY THE INVESTIGATOR. THE PATIENT WAS SUGGESTED OF OUT-PATIENT TREATMENT AT HEMATOLOGY DEPARTMENT, AND THE AE SHOULD BE CHECKED.

  Patient problems: Blood Loss

  MAUDE report 8894985 ↗
• InjuryJun 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY AND PAIN. THE INSERT WAS CHANGED FROM 10 TO 15MM. DOI: (B)(6) 2018, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8735230 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS REVISED ON (B)(6) 2019, TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE IN THE LEFT KNEE. COMPETITOR CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE TIBIAL COMPONENT WAS REMOVED AND REVISED TO MBT REVISION COMPONENT WITH STEM AND SLEEVE. THE ORIGINAL IMPLANT OCCURRED IN (B)(6) 2009.

  Patient problems: No Code Available; Osteolysis; Pain

  MAUDE report 8305409 ↗
• InjuryJan 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL RT TKA WITH ARTHROFIBROSIS.

  Patient problems: Fibrosis; No Code Available; Pain; Scar Tissue

  MAUDE report 8213068 ↗
• InjuryDec 5, 2018Naturally Worn; Naturally Worn

  PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS, WORN POLY AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT AT BONE TO CEMENT INTERFACE.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 8134036 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8047253 ↗
• InjuryNov 2, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 8034342 ↗
• InjuryOct 14, 2018Loss of or Failure to Bond; Biocompatibility; Loss of or Failure to Bond; Biocompatibility

  CLINICAL NOTIFICATION RECEIVED FOR REVISION RELATED TO ASEPTIC LOOSENING/METAL ALLERGY. DOI: (B)(6) 2011, DOR: (B)(6) 2018, (RIGHT KNEE).

  Patient problems: Inadequate Osseointegration; Tissue Damage

  MAUDE report 7963887 ↗
• InjuryNov 17, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 7042260 ↗