P.F.C. SIGMA 1581-24-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295064497), received between Dec 7, 2017 and Jul 31, 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 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL KNEE DONE IN 2013 ROUGHLY. THE PATIENT BECAME INFECTED AND POLY SWAP WAS DONE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22674136 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A POLY CHANGE FOR INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22481448 ↗
• InjuryJun 6, 2024Adverse 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) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19477165 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HE IMPLANT WAS LOOSENING.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 17994620 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17009576 ↗
• InjuryMar 17, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT LOOSE CEMENT BODIES WERE FOUND. CAUSE 3RD BODY WEAR. THE CEMENT WAS REMOVED, NEW POLY INSERTED. NO SURGICAL DELAY. NO FURTHER INFO IS KNOWN AT THIS TIME. DOI: (B)(6) 2017, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 13802707 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INSERT SIZE WAS INCREASED 5MM TO ACCESS INSTABILITY AND SOFT TISSUE LAXITY. NO POLYETHYLENE WEAR. NO LOOSENING. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11744935 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. NO LOOSENING AND NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10393104 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. PATIENT KNEE WAS WASHED OUT. REMOVED INSERT AND PLACED A NEW ONE IN. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10308196 ↗
• InjurySep 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9129547 ↗
• InjurySep 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INSTABILITY. SURGEON REMOVED POLY AND PUT A THICKER INSERT IN. DOI: (B)(6) 2009; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9081841 ↗
• InjuryAug 30, 2018Naturally Worn; Naturally Worn

  PATIENT WAS REVISED TO ADDRESS PAINFUL KNEE. SCAN INDICATED LOOSENING HOWEVER NO LOOSENING WAS FOUND ONCE PRODUCTS WERE TESTED IN THE REVISION. LOOSE FRAGMENT (LOOSE BODY) OF CEMENT CAUSED POLY WEAR. DOI: (B)(6) 2017 DOR: (B)(6) 2018 RIGHT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7832037 ↗
• InjuryJun 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT CORRESPONDENCE INDICATES HE WAS EXPERIENCING PAIN AND DECREASED RANGE OF MOTION PRIOR TO HIS REVISION SURGERY. HE ALSO INDICATES NOW THAT HE HAS NO CONTINUING ISSUES OTHER THAN EXPECTED PAIN FROM THE REVISION SURGERY WITH REHAB. REVISION OF INSERT HAS OCCURRED. DOI: (B)(6) 2010. DOR: (B)(6) 2018.

  Patient problems: Loss of Range of Motion; Not Applicable; Pain; Swelling

  MAUDE report 7620603 ↗
• InjuryMar 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN. THE PATIENT WAS TESTED FOR INFECTION. THE RESULTS WERE POSITIVE. IMPLANTS REMOVED AND REVISION IMPLANTS WERE IMPLANTED. DOI: UNK; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7365343 ↗
• InjuryDec 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7095825 ↗