BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2111205 · Received May 26, 2011

    Report

    Report Number
    1644408-2011-00301
    Event Type
    Other
    Date Received
    May 26, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    G020193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE SURGEON ORIGINALLY PUT THE RSP IN THIS PT ON (B)(6) 2006. ON (B)(6) 2011, THE DR CALLED STATING THAT HE WAS GOING TO PERFORM A REVISION ON THIS PT. THE DR WAS CONVERTING TO A HEMI-ARTHROPLASTY. DURING THE SURGERY, THE DR BEGAN BY REMOVING THE RSP GLENOSPHERE, HUMERAL SOCKET SHELL AND INSERT. WHILE PERFORMING THE REMOVAL THE DR REALIZED THE GLENOID WAS FRACTURED. HE FELT HE MAY BE ABLE TO REDUCE THE FRACTURE BY PUTTING IN THE 3.5MM NON-LOCKING SCREWS INTO THE BASEPLATE. ONCE HE DID THAT, WHILE PUTTING THE ORIGINAL GLENOSPHERE BACK ONTO THE BASEPLATE WITH A NEW RETAINING SCREW, IT BECAME UNSTABLE. THE DR DECIDED TO REMOVE THOSE SCREWS FROM THE BASEPLATE. AFTER REMOVING THE SCREWS FROM THE BASEPLATE, THE DR NOTICED THE 6.5MM BASEPLATE SCREW WAS BROKEN INTO TWO PIECES. HE PROCEEDED TO CONVERT TO A HEMI-ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER GLENOID BASEPLATE KWS ENCORE MEDICAL, L.P. 53782449

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention