P.F.C. SIGMA 1581-25-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295064664), received between Nov 29, 2017 and Jul 7, 2025 — classified as 15 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 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 INFECTED JOINT SPACE. THERE WAS LOOSENING OF FEMUR AT BONE TO CEMENT INTERFACE. THE CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22419925 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI UNKNOWN. DOR (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 20352435 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POLY EXCHANGE FOR INFECTION. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18969518 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POTENTIAL INFECTION. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18229188 ↗
• InjuryNov 9, 2023Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO POLY WEAR. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2004. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18099558 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL LEFT KNEE. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2015. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16427651 ↗
• InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WASHOUT FOR INFECTION. TIBIAL INSERT REMOVED AND NEW ONE IMPLANTED. ORIGINAL SURGERY DONE AT (B)(6) MEDICAL CENTER (B)(6) 2011. RIGHT KNEE WASHOUT. DOI: (B)(6) 2011; DOR: (B)(6) 2022; UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14976250 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VOLUNTARY REPORT RECEIVED (MW5107125) ON (B)(6) 2016 PATIENT UNDERWENT LEFT KNEE COMPUTER ASSISTED TOTAL KNEE ARTHROPLASTY WITH SIZE #5 DEPUY CRUCIATE SUBSTITUTING FEMORAL COMPONENT, SIZE #5 COCR FIX BEARING DEPUY TRAY WITH 10MM POLYETHYLENE INSERT STABILIZED WITH 21MM PATELLAR BUTTON. PATIENT RECOVERED AND WAS DOING WELL UNTIL (B)(6) 2021, PATIENT ADMITTED FOR ARTHROTOMY, SYNOVECTOMY AND REVISION OF TIBIAL INSERT ON (B)(6) 2021. PATHOLOGY REPORT OF SYNOVAL TISSUE OF LEFT KNEE JOINT DIAGNOSIS "GRANULATION TISSUE WITH MILD CHRONIC INFLAMMATION AND METALLOSIS". FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Foreign Body Reaction; Inflammation

  MAUDE report 13890069 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN BELIEVED TO BE CAUSED BY AN INFECTION. THE SURGEON PERFORMED BILATERAL I&D AND POLY EXCHANGE. DOI: (B)(6) 2020. DOR: (B)(6) 2021. LEFT KNEE.

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

  MAUDE report 12018509 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN BELIEVED TO BE CAUSED BY AN INFECTION. THE SURGEON PERFORMED BILATERAL I&D AND POLY EXCHANGE. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 12014186 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD FALLEN AND HAD SOME LAXITY ON THE LATERAL KNEE COMPARTMENT. SURGEON DEBRIDED AND DECIDED TO UPSIZE POLY. DOI: (B)(6) 2017; DOR: (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9553548 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HIS KNEE REPLACED SOMETIME IN 2017, THE EXACT DATE IS UNKNOWN. THE PATIENT CAME TO ER ON (B)(6) 2019 BECAUSE HIS KNEE WAS SWOLLEN, SORE, AND HAD A RASH ON HIS LEG. THE SURGEON WAS ON CALL SO HE WAS ASSIGNED THE CONSULT. HE ASPIRATED THE KNEE AND SEEN PUSS WHICH AT THAT POINT DECIDED TO DO A I&D ON THIS PATIENT¿S KNEE REPLACEMENT. THE SZ 5 X 10MM PS INSERT WAS EXPLANTED AND EXCHANGED WITH A NEW INSERT. THE FEMORAL, TIBIAL, AND PATELLA COMPONENTS WERE LEFT IMPLANTED. THE LOT # COULD NOT BE READ SO THE LOT # COULD NOT BE DOCUMENTED. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Discomfort; Edema; No Code Available; Rash; Unspecified Infection

  MAUDE report 9413222 ↗
• InjuryMay 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL COMPONENTS WERE REMOVED AND COMPETITOR ANTIBIOTIC SPACER WAS IMPLANTED. DOI: (B)(6) 2019. DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8647020 ↗
• InjuryMar 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES PATIENT¿S MAIN COMPLAINT WAS KNEE PAIN POST PRIMARY TOTAL KNEE. THE SURGEON EVALUATED THE PATIENT AND SAW A SLIGHT LAXITY DURING THE EVALUATION. HE RECOMMENDED A POLY EXCHANGE AND POSSIBLE REVISION IF COMPONENTS ARE LOOSE. THERE WAS AN EXCESSIVE AMOUNT OF SCARRING THROUGHOUT THE JOINT SPACE. HE REMOVED THE TIBIAL INSERT AND CONTINUED CLEARING SCAR TISSUE FROM THE BACK OF THE KNEE. HE INSERTED THE SIZE 5 12.5MM INSERT TRIAL TO DETERMINE PROPER FLEXION/EXTENSION STABILITY. HE ALSO PERFORMED SOME SOFT TISSUE BALANCING. THE SIZE 5 12.5MM POLY INSERT WAS INSERTED AND CHECKED TO SEE IF LOCKED INTO TIBIAL TRAY. IT WAS SEATED. THERE WERE NO INSTRUMENTS BROKEN DURING THE CASE. SURGEON WAS HAPPY WITH THE OUTCOME. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: No Code Available; Pain; Scarring

  MAUDE report 7316668 ↗
• InjuryNov 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS A DRAINING SINUS AND WAS BROUGHT TO OR FOR I&D VS. REVISION. IT WAS CONFIRMED THAT THE TRACT WENT UNTO THE JOINT. IT WAS ALSO REPORTED THAT ALL COMPONENTS WERE REMOVED AND A ONE STAGE REVISION WAS PERFORMED. FROZEN SECTION WAS PERFORMED AND INFECTION WAS CONFIRMED.

  Patient problems: Unspecified Infection

  MAUDE report 7066871 ↗