BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 6201558 · Received December 22, 2016

    Report

    Report Number
    1644408-2016-01043
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    December 1, 2016
    Report Date
    February 10, 2017
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    UDI-DI
    00888912024761
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS THE PATIENT DISLOCATED THEIR SHOULDER. THE IN-VIVO LENGTH OF PATIENT SERVICE FOR THE IMPLANT WAS 5.6 MONTHS. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) REVEALED NO DISCREPANCIES OR ISSUES WITH THE MANUFACTURING OF THIS PART. ALL CRITICAL DIMENSIONS AND SPECIFICATIONS IN EFFECT AT THE TIME THE PART WAS MANUFACTURED WERE MET. THE PRODUCT COMPLAINT REPORT HISTORY WAS REVIEWED AND NO TRENDS OR ON-GOING ISSUES WERE DEEMED AS PRESENT OR IN NEED OF REVIEW. THIS EVENT IS DEEMED AS NON-PRODUCT RELATED. THE ROOT CAUSE FOR THE PATIENT DISLOCATING THEIR SHOULDER WAS REPORTED AS PLAYING TACKLE FOOTBALL. THE SCOPE OF THIS INVESTIGATION IS LIMITED WITHOUT HAVING THE PARTS AVAILABLE TO DJO SURGICAL FOR EVALUATION. OTHER CONDITIONS RELATING TO THIS EVENT COULD NOT BE DETERMINED WITH CONFIDENCE. INVENTORY CONTAINMENT IS NOT REQUIRED SINCE THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE PATIENT DECIDING TO PLAY TACKLE FOOTBALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848585 RSP SHOULDER GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL KWS ENCORE MEDICAL, L.P. 869C2072 00888912024761

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention 508-00-036, LOT 856C1919