BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYLAMER 10D 54OD X 28ID

    MDR report key: 1222497 · Received November 5, 2008

    Report

    Report Number
    1818910-2008-05163
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 20, 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
    IA, 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 WOULD 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. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFO THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT REVISED TO ADDRESS POLYETHYLENE WEAR OF LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYLAMER 10D 54OD X 28ID 87HRY HRY DEPUY ORTHOPAEDICS, INC. NA 876320016

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention