P.F.C. SIGMA 1581-12-108Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295063261), received between Feb 19, 2018 and Aug 12, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. POLY WAS SWAPPED AND JOINT WAS WASHED OUT. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22785322 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 14073538 ↗
• MalfunctionJul 24, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED AS - PRODUCT NAME: PFC SIGMA TIBIAL INSERT FIXED BEARING CURVED REF: 1581-12-108. LOT: 9252237. EXPIRY DATE:8/31/2024. BILATERAL TOTAL KNEE REPLACEMENT. USING SIGMA PFC ON (B)(6) 2020 IN (B)(6) HOSPITAL. SURGEON NAME (B)(6). FIRST CASE AT 8 AM. OPERATED ON LEFT KNEE FIRST, IMPLANT OPENED AT 10.30 AM. 2 DEFECTS FOUND WHEN IMPLANT OPENED FROM STERILE PACK. RIGHT SIDE POSTERIOR VIEW OF IMPLANT, LOOK SLIGHTLY "BUMPER" AND LOCKING MECHANISM UNDER INSERT ON RIGHT SLIGHTLY FLANGED OUT. IMPLANT WASN¿T IMPLANTED IN PATIENT. SURGEON DECIDED TO IMPLANT A THICKER INSERT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10323097 ↗
• InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WASHOUT & POLY BEARING EXCHANGE. PATIENT UNDERWENT PRIMARY TKR WHERE A PFC WAS UTILIZED. PATIENT HAS PRESENTED A PAINFUL AND INFECTED KNEE. A DECISION WAS MADE TO PERFORM A WASHOUT AND POLY EXCHANGE, THE CASE TOOK PLACE AND THE BEARING WAS IN FACT EXCHANGED.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 9835885 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS SLIGHT INSTABILITY. SURGEON REMOVED THE POLY AND IMPLANTED A THICKER SIZE TO HELP STABILITY. DOI: (B)(6) 2017. DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9079123 ↗
• InjuryJan 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8285527 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS SCHEDULED FOR I&D DUE TO INFECTION. SURGEON CHANGED OUT POLY.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8256735 ↗
• InjuryFeb 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION TKR DR (B)(6), (B)(6) HOSPITAL (B)(6) 2018. PATIENT UNDERWENT PRIMARY TKR ON (B)(6) 2013 (DR (B)(6), (B)(6) HOSPITAL). PATIENT HAS PRESENTED WITH A PROGRESSIVELY PAINFUL KNEE AND REDUCED RANGE OF MOTION. X RAYS APPEAR TO SHOW SOME ABNORMAL ACTIVITY BELOW THE TIBIAL TRAY. BONE SCANS SHOWN"HOT" AREAS BELOW THE TIBIAL TRAY. TIBIAL LOOSENING WAS SUSPECTED. ON OPENING THE KNEE (DR (B)(6), (B)(6) HOSPITAL) THE TIBIAL TRAY APPEARED TO BE FAIRLY WELL FIXED. THE BONE CEMENT WAS WELL FIXED TO THE UNDERLYING BONE. THE TIBIAL TRAY WAS REMOVED ALONG WITH THE CEMENT. AN MBT REVISION TRAY WITH SLEEVE AND STEM IMPLANTED. A NEW 10MM CR INSERT WAS IMPLANTED. KNEE APPEARED STABLE ON THE TABLE . (B)(6).

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 7280478 ↗