BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNUM HEAD

    MDR report key: 3853598 · Received June 6, 2014

    Report

    Report Number
    3002806535-2014-00143
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT WAS RETURNED TO MANUFACTURER. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. EXPIRATION DATE - UNKNOWN; DEVICE MANUFACTURE DATE - UNKNOWN;

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REPLACEMENT SURGERY ON AN UNKNOWN DATE. A REVISION PROCEDURE DUE TO UNKNOWN REASONS WAS ATTEMPTED ON (B)(6) 2014, BUT DURING SURGERY, THE HEAD COULD NOT BE REMOVED FROM THE TAPER ADAPTOR. AFTER SEVERAL ATTEMPTS, THE SURGEON DECIDED TO STOP THE SURGERY AND RESCHEDULE FOR A LATER DATE AFTER FIGURING OUT HOW TO REMOVE THE ADAPTOR. NO NEW REVISION HAS OCCURED TO DATE AND NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331185 MAGNUM HEAD PROSTHESIS, HIP KWA BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R