BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM INSRT S22, 10DEG, 22MM

    MDR report key: 1870593 · Received October 12, 2010

    Report

    Report Number
    1818910-2010-07686
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 12, 2010
    Report Date
    September 12, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K924492
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS POLY WEAR OF THE LINER. IT WAS NOTED THAT METALOSIS WAS VISIBLE DUE TO HEAD WEARING THROUGH THE LINER AND INTO THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM INSRT S22, 10DEG, 22MM 87LPH LPH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention