BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOID, POLY WITH KEEL, LARGE

    MDR report key: 1981814 · Received February 8, 2011

    Report

    Report Number
    1220246-2011-00017
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 21, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    PMA / PMN Number
    K010124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    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 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. THE MOST LIKELY CAUSE(S) OF THE EVENT INCLUDE IMPROPER SEATING OF THE DEVICE( GLENOID WAS NOT IMPLANTED DEEP ENOUGH OR NOT WELL FIXATED DUE TO AN INADEQUATE USE OF CEMENT). THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT NUMBER COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. UNKNOWN DEVICE DISPOSITION.

    Description of Event or Problem · 1

    REVISION CASE. GLENOID WAS FLOATING IN JOINT. ACCORDING TO RADIOLOGY, GLENOID COMPLETELY DISSOCIATED A COUPLE CENTIMETERS. SURGERY INVOLVED REMOVING THE KEELED COMPONENT AND IMPLANTING A NEW PEG GLENOID AND NEW HUMERAL HEAD. ORIGINAL TOTAL SHOULDER SURGERY WAS (B)(6) 2008.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other