BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER SYSTEM

    MDR report key: 1552316 · Received December 3, 2009

    Report

    Report Number
    1644408-2009-00569
    Event Type
    Other
    Date Received
    December 3, 2009
    Date of Event
    November 11, 2009
    Report Date
    November 11, 2009
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSD
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - 2ND REVISION. PT DISLOCATED RSP 2ND TIME (SOFT TISSUE ISSUES) REQUIRED CUSTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER SYSTEM GLENOID HEAD W/RETAINING SCREW HSD ENCORE MEDICAL, L.P. 53973248

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention IMPLANTED: AT FIRST REVISION| (B)(4)| (B)(4)| IMPLANTED: AT FIRST REVISION