BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR RED/LAT 17.5X155

    MDR report key: 3087704 · Received May 1, 2013

    Report

    Report Number
    0001825034-2013-01225
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 2, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    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 DEVIATION OR ANOMALY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. UNDER WARNINGS, NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO A PERIPROSTHETIC FRACTURE. THE HEAD, STEM, AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189182 TAPERLOC POR RED/LAT 17.5X155 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 802690

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R