BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALORY-HEAD POROUS FEMORAL 7X140MM

    MDR report key: 3233639 · Received July 18, 2013

    Report

    Report Number
    0001825034-2013-02739
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    December 3, 2003
    Report Date
    June 18, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK921181
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 THAT A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2003, DUE TO PERIPROSTHETIC FRACTURE. THE STEM AND HEAD WERE REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333192 MALORY-HEAD POROUS FEMORAL 7X140MM PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 166890

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R