BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS HMRL TI TRAY 44MM

    MDR report key: 3981653 · Received August 5, 2014

    Report

    Report Number
    0001825034-2014-06836
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    May 16, 2014
    Report Date
    July 10, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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 THAT 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 1 STATES, " MATERIAL SENSITIVITY REACTIONS." NUMBER 9 STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06829 & 06836).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT COMPREHENSIVE REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY PATIENT WAS REVISED ON (B)(6) 2014 DUE TO THE POST FRACTURING FROM THE HUMERAL TRAY ON THE HUMERAL STEM. POST OPERATIVE REPORT NOTED LOOSE METAL AND METALLOSIS DURING THE REVISION PROCEDURE. THE HUMERAL BEARING, HUMERAL TRAY AND HUMERAL STEM WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457373 COMP RVS HMRL TI TRAY 44MM PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A 697180

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R