P.F.C. SIGMA 1581-13-108Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295063384), received between Aug 25, 2017 and Sep 16, 2022 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. THERE WAS NO REPORTED LOOSENING. IT WAS UNKNOWN IF ANY SURGICAL DELAY OCCURRED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 15441796 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTION. EXPLANTED THE FEMORAL COMPONENT SZ 4N SIGMA CR, THE SZ 3 SIGMA FB TRAY, THE SZ 3,8MM FB CURVED INSERT, AND THE PATELLA. CLEAN UP CUTS WERE MADE AND THE SURGEON IMPLANTED AN ATTUNE CR SZ 6 FEMUR WITH AN ALPOLY CR 10MM INSERT AS A TEMPORARY CEMENT MOLD. NOTHING WAS DONE FOR THE PATELLA. NO INJURY TO THE PATIENT AND NO DELAY IN SURGERY. THIS WAS THE PATIENTS RIGHT KNEE. I WAS TOLD THE ORIGINAL SURGERY WAS 12 OR 13 YRS AGO. NO IMPLANT LOG AVAILABLE. DOI: UNK, DOR: (B)(6) 2022, UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 15163080 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS PERIPROSTHETIC DISTAL SUPRACONDYLAR FEMUR FRACTURE - DEGLOVING INJURY. DATE OF IMPLANTATION: (B)(6) 2005, DATE OF REVISION: (B)(6) 2021, (LEFT KNEE). TREATMENT: FEMUR, TIBIAL TRAY, AND INSERT COMPONENTS REVISED.

  Patient problems: Fall; Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 12881943 ↗
• InjuryNov 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT KNEE REVISION - REMOVED FEMUR, INSERT AND TIBIA TO TREAT ARTHROFIBROSIS. NO DELAY. NO BROKEN INSTRUMENTS. DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 12850007 ↗
• InjuryAug 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO UNSTABLE KNEE FLEXION AND EXTENSION. REVISED TO CURVED PLUS 12.5MM INSERT. INSTABILITY WAS NOT RELATED TO POLY WEAR. COMPONENTS WERE NOT UNDERSIZED. FEMORAL AND TIBIAL RESECTIONS WE¿RE NOT EXCESSIVE. NO SURGICAL DELAY. DOI: (B)(6) 2016. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12269231 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  QUESTIONS: 1. THE HOSPITAL INDICATED IN THE DER IS UNCLEAR. PLEASE PROVIDE THE HOSPITAL/ACCOUNT WHERE THE REVISION SURGERY WAS PERFORMED. 2. IS A RESPONSE LETTER REQUESTED? IF YES, FOR WHOM? 3. CAN YOU PLEASE CONFIRM IF ALL IMPLANTS ON THE IMPLANT STICKER SHEET (FEMUR, TIBIA, INSERT AND PATELLA) WERE REVISED/EXPLANTED? IF NOT, WHAT IMPLANTS WERE REVISED? ANSWERS: (B)(6) HOSPITAL. NO LETTER. EVERYTHING WAS EXPLANTED EXCEPT FOR PATELLA.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11827162 ↗
• InjuryMar 4, 2021Naturally Worn; Naturally Worn

  PATIENT UNDERWENT A KNEE REVISION TO TREAT LOOSENING OF THE FEMORAL COMPONENT AND TIBIAL TRAY AT AN UNKNOWN INTERFACE. THERE WAS NOTED WEAR ON THE TIBIAL INSERT AND A TIBIAL CYST. TH TIBIAL VOID WAS FILLED WITH CEMENT. DOI: 2014, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Insufficient Information

  MAUDE report 11418195 ↗
• InjuryMay 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY TOTAL KNEE REPLACEMENT ON (B)(6) 2013 WHERE A PFC SIGMA WAS UTILIZED. PATIENT HAS REPORTED THAT SHE NEVER FELT COMFORTABLE AND THAT IT WAS NOT LONG AFTER THE PRIMARY TKR THAT SHE BEGAN TO EXPERIENCE ANTERIOR KNEE PAIN. X RAYS OF THE KNEE APPEAR TO BE ACCEPTABLE, THE PATELLA APPEARS TO BE A PATELLA BAHA. A DECISION WAS MADE TO REVISE THE COMPONENTS AND IMPLANT AN ATTUNE REVISION SYSTEM. ON OPENING THE KNEE, ALL COMPONENTS APPEARED TO BE WELL FIXED. THE FEMORAL AND TIBIAL COMPONENTS WERE REMOVED AND THE PATELLA LEFT IN SITU. THE TIBIA WAS DISTALIZED AND THE FEMUR SUBSEQUENTLY BALANCED BY DISTALIZED AND UP SIZING.

  Patient problems: No Code Available; Pain

  MAUDE report 10075110 ↗
• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF RIGHT TKA. SIGMA FB CR. IMPLANTED (B)(6) 2019. INFECTION. BOTH FEMUR AND TIBIA LOOSE, SURGEON DETERMINED THIS WAS A RESULT OF INFECTION. IMPLANTS REMOVED, ANTIBIOTIC SPACERS IMPLANTED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9610886 ↗
• InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9219409 ↗
• InjuryAug 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6820094 ↗