BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC MICROP LAT FMRL 17.5M

    MDR report key: 3101332 · Received May 9, 2013

    Report

    Report Number
    0001825034-2013-01318
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK062994
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. 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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED (B)(6) 2013 DUE TO FEMUR STRESS FRACTURE AROUND THE STEM. THE STEM AND HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202899 TAPERLOC MICROP LAT FMRL 17.5M PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 472950

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R