P.F.C. SIGMA 1581-25-108Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295064657), received between May 17, 2018 and Aug 12, 2026 — classified as 11 injuries, 2 malfunctions.

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

• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50226536 ↗
• InjuryJun 6, 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 INSTABILITY. SURGEON DID DEBRIDEMENT AND EXCHANGED INSERT TO 10MM. THERE WAS NO ADVERSE CONSEQUENCE AND NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22157737 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINED OF KNEE PAIN. UPON REVIEW ON X-RAY, TIBIAL COMPONENT LOOKED LOOSE AND SLIGHTLY COLLAPSED INTO VARUS. THERE WAS SIGNIFICANT WEAR AROUND THE FEMUR AS WELL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. DOI: (B)(6) 2011, DOR: (B)(6) 2025, AFFECTED AREA: RIGHT KNEE.

  Patient problems: Osteolysis; Pain

  MAUDE report 21988213 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO SWAP POLY FOR AN UNKNOWN REASON. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21884778 ↗
• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT NO DELAYS IN SURGERY OCCURRED OR ANY PATIENT HARMS WERE REPORTED. THE EVENT OCCURRED DURING PRIMARY SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 18101243 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. WASHOUT AND POLY EXCHANGE PERFORMED. DOI: UNKNOWN, DOR: (B)(6), 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17479435 ↗
• MalfunctionJul 21, 2023Device Damaged Prior to Use; Defective Device; Device Damaged Prior to Use; Defective Device

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT ONE OF THE SIDES OF THE PRODUCT WAS BURR WHICH MADE THE INSERTION IMPOSSIBLE. THIS CAUSED A 1-HOUR SURGICAL DELAY AND THE SURGEON HAD TO USE A TC3 INSERT CONFIRMING ADVERSE CONSEQUENCES OCCURRED TO THE PATIENT. THIS EVENT OCCURRED DURING PRIMARY SURGERY ON THE RIGHT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 17369847 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POLY EXCHANGE DUE TO INFECTION. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15232940 ↗
• MalfunctionMay 31, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE IMPLANT WAS NOT FITTED AS IT SHOULD, SO HE REQUESTED THE OPENING OF ANOTHER UNIT OF THE SAME CODE. 5 MINUTE DELAY.

  Patient problems: Insufficient Information

  MAUDE report 14547210 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10482910 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. I&D WITH POLY EXCHANGE WAS PERFORMED. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9591445 ↗
• InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS KNEE WAS BELIEVED TO BE INFECTED. COMPONENTS REMOVED AND REPLACED IN A ONE STAGE REVISION WITH PLACEMENT OF ANTIBIOTIC BEADS. NO LOT AVAILABLE FOR CEMENT AS IT IS HOSPITAL INVENTORY. DOI: (B)(6) 2019, DOR: (B)(6) 2019 LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9297339 ↗
• InjuryMay 17, 2018Noise, Audible; Noise, Audible

  PATIENT PRESENTED IN CLINIC WITH A UNSTABLE LEFT KNEE, ¿CLICKING¿, AND MEDIAL PAIN. DR. (B)(6) DECIDED A FULL REVISION WAS BEST CORRECTIVE ACTION. DR. (B)(6) REMOVED FEMUR, INSERT, AND TIBIA AND REPLACED WITH REVISION COMPONENTS. THERE WAS NO LOOSENING OF THE COMPONENTS. THERE WAS NO MENTION OF THE PRODUCTS NOT DOING WHAT THEY WERE SUPPOSED TO. NO INSTRUMENTATION BROKE DURING SURGERY AND THERE WERE NO DELAYS. INDEX SURGERY WAS PERFORMED BY DR. (B)(6) AT (B)(6) COMMUNITY HOSPITAL ON (B)(6) 2012. DR. (B)(6) ELECTED TO KEEP THE PATELLA IMPLANTED.

  Patient problems: No Code Available; Not Applicable; Pain

  MAUDE report 7522356 ↗