BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCISSUM RT TRI FLANGE SZ26

    MDR report key: 3051363 · Received April 10, 2013

    Report

    Report Number
    0001825034-2013-00909
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "IMPLANTS CAN LOOSEN OR MIGRATE DUE TO TRAUMA OR LOSS OF FIXATION."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION HIP ARTHROPLASTY TO REMOVE AND REPLACE COMPETITOR PRODUCT WITH A CUSTOM BIOMET TRIFLANGE ACETABULAR CUP ON (B)(6) 2013. SUBSEQUENTLY, THE PATIENT AMBULATED AND PLACED WEIGHT ON THE LEG AND RADIOGRAPHS TAKEN ON (B)(6) 2013 REVEALED THE TRIFLANGE COMPONENT PULLED AWAY FROM THE BONE AT THE ISCHIUM. THE PATIENT WAS TAKEN BACK INTO SURGERY ON (B)(6) 2013 TO SECURE THE TRIFLANGE COMPONENT AND THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149411 SCISSUM RT TRI FLANGE SZ26 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 781390

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R