BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE +6 36MM

    MDR report key: 3964935 · Received July 29, 2014

    Report

    Report Number
    0001825034-2014-06518
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 3, 2014
    Report Date
    October 1, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION AND/OR EXCESSIVE ACTIVITY." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06515 AND 06518).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO LIKELY BE DUE TO PATIENT'S POOR GLENOID BONE STOCK.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. DATE OF REVISION / EXPLANT- (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, THE PATIENT WAS REVISED ON AN UNKNOWN DATE DUE TO LOOSENING OF THE GLENOID BASEPLATE. ALL COMPONENTS EXCEPT THE STEM WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO LOOSENING OF THE GLENOID BASEPLATE. ALL COMPONENTS EXCEPT THE STEM WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440723 COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE +6 36MM PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 413660

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R