BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POROUS LATERAL FEMORAL 17.5X155

    MDR report key: 3083292 · Received April 29, 2013

    Report

    Report Number
    0001825034-2013-01188
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK921301
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: "POSTOPERATIVE BONE FRACTURE AND PAIN."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO FRACTURE OF THE PATIENT'S FEMUR. THE FEMORAL STEM AND HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183960 TAPERLOC POROUS LATERAL FEMORAL 17.5X155 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 105010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R