BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC MICROPLASTY FEMORAL 11MM X 107.5MM POROUS

    MDR report key: 2013747 · Received March 10, 2011

    Report

    Report Number
    1825034-2011-00183
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    June 20, 2006
    Report Date
    February 11, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBL
    PMA / PMN Number
    K050441
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006 AS PART OF A CLINICAL STUDY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2006 DUE TO PERIPROSTHETIC FRACTURE. THE FEMORAL COMPONENT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPERLOC MICROPLASTY FEMORAL 11MM X 107.5MM POROUS PROSTHESIS, HIP MBL BIOMET ORTHOPEDICS N/A 646520

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R