BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MODULAR HUMERAL HEAD 44MM X 22MM

    MDR report key: 6228580 · Received January 6, 2017

    Report

    Report Number
    0001825034-2017-00044
    Event Type
    Injury
    Date Received
    January 6, 2017
    Date of Event
    December 7, 2016
    Report Date
    May 31, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSD
    PMA / PMN Number
    PK030710
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." NUMBER 13 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." MEDICAL PRODUCT ¿ COMP PRIMARY STEM 11MM STD, CATALOG#: 113651 LOT#: 033640, THERAPY DATE - (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THIS REPORT IS A DUPLICATE OF 1825034-2016-05399. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A RIGHT SHOULDER REVISION APPROXIMATELY TEN YEARS POST-IMPLANTATION DUE TO PAIN. IT WAS NOTED THAT THE HUMERAL HEAD HAD MIGRATED SUPERIORLY TO THE GLENOID AND THE ROTATOR CUFF WAS NON-FUNCTIONAL. THE HUMERAL HEAD WAS EXPLANTED AND THE PATIENT WAS CONVERTED TO A REVERSE TOTAL SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13866 BIO-MODULAR HUMERAL HEAD 44MM X 22MM PROSTHESIS, SHOULDER HSD BIOMET ORTHOPEDICS N/A 516790

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R