BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYLAMER 10D 58 OR 70ODX28ID

    MDR report key: 1143645 · Received August 28, 2008

    Report

    Report Number
    1818910-2008-03791
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 5, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWY
    PMA / PMN Number
    K940743
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE LOT CODE REQUIRED FOR RETRIEVAL WAS UNAVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE OF INSTABILITY WITH WEAR OF THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYLAMER 10D 58 OR 70ODX28ID 87KWY KWY DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention