BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYLAMER NEUT 54OD X 28ID

    MDR report key: 2230385 · Received September 1, 2011

    Report

    Report Number
    1818910-2011-17103
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 25, 2011
    Report Date
    August 28, 2011
    Manufacturer
    DEPUY WARSAW
    Product Code
    JDL
    PMA / PMN Number
    K900832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT PRODUCTS WILL NOT BE RETURNED FOR INVESTIGATION BECAUSE THEY ARE NOT RETURNED FROM THE HOSPITAL. AFTER THE FIRST REQUEST FOR X-RAYS, WE WERE INFORMED ON THE (B)(6) 2011 THAT NO X-RAYS WERE AVAILABLE. AS THERE WAS NO FURTHER INFORMATION AVAILABLE, THE COMPLAINT WAS TRANSFERRED TO INVESTIGATION ON (B)(6) 2011. REVIEW OF ETQ COMPLAINTS DATABASE FOR LOT NUMBERS 799300 AND WDR-69 IDENTIFIED NO PREVIOUS COMPLAINTS. AS THERE WERE NO PRODUCTS RETURNED, NO FURTHER INVESTIGATION COULD TAKE PLACE. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO IMPLANT WEAR AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYLAMER NEUT 54OD X 28ID HIP JDL DEPUY WARSAW 799300

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention