BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS HMRL TI TRAY 44MM

    MDR report key: 4251478 · Received November 14, 2014

    Report

    Report Number
    0001825034-2014-08614
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 16, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. LOT NUMBER AND EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 10 STATES " FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A COMPREHENSIVE REVERSE TOTAL SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO A FRACTURED HUMERAL TRAY FROM BENCH PRESSING. THE HUMERAL TRAY AND HUMERAL BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736611 COMP RVS HMRL TI TRAY 44MM PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R