BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOID, PE WITH PEG, LARGE

    MDR report key: 1932679 · Received December 20, 2010

    Report

    Report Number
    1220246-2010-00261
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 8, 2010
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    PMA / PMN Number
    K083435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FOLLOW-UP SUBMISSION TO CHANGE THE DEVICE LOT NUMBER TO 0919007 FROM 0919006. NO ADDITIONAL CHANGES WERE MADE. UNKNOWN DEVICE DISPOSITION.

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.THE EXPLANTED DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED, THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT.BASED ON THE INFORMATION PROVIDED, THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT ( REMOVAL OF THE GLENOID IMPLANT) IS THE TRAUMA SUSTAINED FROM THE MOTOR VEHICLE EVENT.THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. H3 OTHER TEXT : UNKNOWN DEVICE DISPOSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT SOMETIME AFTER INITIAL SURGICAL PROCEDURE USING UNIVERS LL PEGGED GLENOID IMPLANT. A REVISION PROCEDURE WAS PERFORMED AND THE GLENOID IMPLANT WAS REMOVED. THE IMPLANT WAS NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLENOID, PE WITH PEG, LARGE PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. 0919007

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other