BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYLAMER 10D 52OD X 28ID

    MDR report key: 1211034 · Received October 23, 2008

    Report

    Report Number
    1818910-2008-04780
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HRY
    PMA / PMN Number
    K944538
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODE SINCE ITS RELEASE FOR DISTRIBUTION. ALTHOUGH UNAVAILABLE FOR EVALUATION, IT WOULD NOT BE UNREASONABLE TO EXPECT POLY MATERIAL WEAR AFTER APPROXIMATELY 12 YEARS OF IMPLANTATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS POLY WEAR AND OSTEOLYSIS (LEFT SIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYLAMER 10D 52OD X 28ID 87HRY HRY DEPUY ORTHOPAEDICS, INC. NA 610880007

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention