BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 1943574 · Received December 6, 2010

    Report

    Report Number
    1644408-2010-00652
    Event Type
    Other
    Date Received
    December 6, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT DEVELOPED AN INFECTION, THE DOCTOR DECIDED TO PERFORM AN IRRIGATION AND DEBRIDEMENT OF THE SURGERY SITE AND SWITCH OUT THE SHELL AND POLY LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER HUMERAL SOCKET INSERT HSD ENCORE MEDICAL, L.P. 855C1008

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention