BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS HMRL TI TRAY 44MM

    MDR report key: 4020255 · Received August 19, 2014

    Report

    Report Number
    0001825034-2014-07150
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    July 30, 2014
    Report Date
    May 12, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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 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 PATIENT UNDERWENT A COMPREHENSIVE REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO A FRACTURED HUMERAL TRAY AFTER HEAVY LIFTING. THE HUMERAL TRAY AND HUMERAL BEARING WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE REPORT NOTED PATIENT WAS REVISED ON (B)(6) 2014 DUE TO PAIN AND A FRACTURED HUMERAL BASEPLATE. THE HUMERAL COMPONENTS AND TAPER WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A COMPREHENSIVE REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO A FRACTURED HUMERAL TRAY AFTER HEAVY LIFTING. THE HUMERAL TRAY AND HUMERAL BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498167 COMP RVS HMRL TI TRAY 44MM PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A 607420

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R