BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 3970462 · Received July 31, 2014

    Report

    Report Number
    1644408-2014-00493
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 26, 2014
    Report Date
    July 26, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K041066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION WAS A FRACTURE OF THE HUMERUS CAUSING THE STEM TO SUBSIDE AND COMPRISE STRUCTURE OF THE JOINT. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. HOSPITALIZATION - INITIAL OR PROLONGED WAS REQUIRED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. (B)(4). A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THIS FIRST COMPLAINT AGAINST LOT NUMBER 816C1090. THERE HAVE BEEN A TOTAL OF 15 COMPLAINTS AGAINST THIS PART NUMBER; 4 FROM PATIENT TRAUMAS RESULTING FROM A FALL WITH THE REMAINDER ATTRIBUTABLE TO DISLOCATION, INSTABILITY AND INFECTION. THE ROOT CAUSE FOR THE FRACTURE OF THE HUMERUS CAUSING THE HUMERAL STEM TO SUBSIDE WAS NOT REPORTED. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE STEM SUBSIDED AND COMPROMISED THE STRUCTURE OF THE JOINT DUE TO A FRACTURE OF THE HUMERUS. THE SURGEON PUT IN A LONGER STEM AND A BIGGER INSERT. ORIGINAL (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447428 RSP SHOULDER RSP PRIMARY HUMERAL STEM 10 X 116MM KWS ENCORE MEDICAL, L.P. 816C1090

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| O| R