BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS HMRL TI TRAY 44MM

    MDR report key: 4241738 · Received November 10, 2014

    Report

    Report Number
    0001825034-2014-08579
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    February 14, 2011
    Report Date
    December 4, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2011 WAS PREVIOUSLY REPORTED ON MANUFACTURER REPORT NUMBER 1825034-2011-00142.

    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: ¿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 NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-08297 & 08579 / 08580).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A COMPREHENSIVE REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2011 DUE TO A FRACTURED HUMERAL TRAY TRUNNION. THE PATIENT UNDERWENT A SECOND REVISION PROCEDURE ON (B)(6) 2014 DUE TO A FRACTURED HUMERAL TRAY TRUNNION. DURING THE PROCEDURE, THE TRUNNION WOULD NOT DISENGAGE FROM THE STEM AND THE STEM COULD NOT BE REMOVED FROM THE PATIENT'S HUMERUS. THE HUMERUS WAS SPLIT IN ORDER TO COMPLETE THE PROCEDURE. THE STEM, TRAY AND BEARING WERE REMOVED AND REPLACED. A DELAY GREATER THAN 30 MINUTES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723942 COMP RVS HMRL TI TRAY 44MM PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A 848200

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R