BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA C/S NPOR FEM RT SZ 5

    MDR report key: 10542289 · Received September 16, 2020

    Report

    Report Number
    1818910-2020-20277
    Event Type
    Injury
    Date Received
    September 16, 2020
    Date of Event
    June 24, 2013
    Report Date
    September 2, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295232407
    PMA / PMN Number
    K950010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). THIS PRODUCT WAS REPORTED IN ERROR SINCE MRN WAS FOUND TO BE A DUPLICATE REPORT OF MRN 1818910-2013-212954. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION OPERATIVE NOTES (B)(6) 2013 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO LOOSE AND PAINFUL RIGHT TOTAL KNEE. UPON ENTERING THE JOINT, METAL STAINED FLUID WAS ENCOUNTERED, SYNOVIUM SHOWED SEVERE METAL STAINING. SCAR TISSUE WAS DEBRIDED. THE TIBIAL INSERT WAS NOTED TO HAVE SLIGHT WEAR. THE TIBIAL AND FEMORAL COMPONENTS WERE STATED TO BE LOOSE, INTERFACE NOT PROVIDED. THE PATELLA WAS ALSO NOTED TO HAVE MINIMAL WEAR, IT WAS NOT REVISED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. PRODUCTS IMPLANTED AT THIS REVISION ARE LOCATED ON PAGE 13-15. DOI: (B)(6) 2004 DOR: (B)(6) 2013 RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004456 PFC*SIGMA C/S NPOR FEM RT SZ 5 SIGMA KNEE PRIMARY : KNEE FEMORAL JWH DEPUY ORTHOPAEDICS INC US 96-0055 3140055K 10603295232407

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention P.F.C.* TIB STM EXT 4/5/6 30MM.| PFC SIGMA FEM POST AUG SZ5 4MM.| PFC SIGMA FEM POST AUG SZ5 4MM.| PFC SIGMA MOD TIB TRAY CEM SZ4.| PFC SIGMA STAB INS SZ4 12.5MM.| PFC*SIGMA C/S NPOR FEM RT SZ 5.| PFC*SIGMA/OV/DOME PAT 3PEG,41.| PFCSIGMA FEMCEMSTEM15X90MM7DEG.| RADIOPAQUE BONE CEMENT (STYRKER).| RADIOPAQUE BONE CEMENT (STYRKER).| RADIOPAQUE BONE CEMENT (STYRKER).