BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON 10D 56 OR 68ODX28ID

    MDR report key: 2349971 · Received November 28, 2011

    Report

    Report Number
    1818910-2011-24655
    Event Type
    Injury
    Date Received
    November 28, 2011
    Date of Event
    November 9, 2011
    Report Date
    November 16, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWY
    PMA / PMN Number
    K940743
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. ETQ COMPLAINTS DATABASE SEARCHED ON PRODUCT LOT 1176599, 1914264, WHH-73, WDH-90, X32DH1, IDENTIFIED NO SIMILAR COMPLAINTS RECEIVED PREVIOUSLY. FOLLOWING INVESTIGATION BY BIOENGINEERING, NOTIFICATION WAS RECEIVED THAT: ROOT CAUSE: UNDETERMINED, CURRENTLY THERE IS INSUFFICIENT INFORMATION AVAILABLE TO DETERMINE A CAUSE OF THIS IMPLANT FAILURE. THE COMPLAINT SHALL BE CLOSED WITH AN INDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT SUSPECTED OF ALVAL. REVISION ON (B)(6) 2011. A PATIENT SAID, HE COULDN'T GENERATE FORCE ON HIS RIGHT LEG. BIG OSTEOLYSIS WAS CONFIRMED AROUND ACETABULAR CUP. THE CUP, THE LINER AND THE HEAD WERE REMOVED AND REPLACED . THERE WERE A LOT OF YELLOWISH WHITE TUMOR. JUNCTION OF THE HEAD AND THE STEM NECK, THERE WAS METAL DEBRIS. THE CUP WAS LOOSE, THE SCREW HAD BROKEN DURING REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURON 10D 56 OR 68ODX28ID HIP KWY DEPUY INTERNATIONAL 1914264

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention