BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MOD ST.10X115 W/ALIGN HOLE

    MDR report key: 3222653 · Received July 12, 2013

    Report

    Report Number
    0001825034-2013-02650
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSD
    PMA / PMN Number
    PK030710
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 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 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION AND/OR EXCESSIVE ACTIVITY." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02650 / 02651).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A SHOULDER ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, PATIENT WAS ON (B)(6) 2012 DUE TO UNKNOWN REASONS. THE HUMERAL HEAD WAS REMOVED AND REPLACED. ON (B)(6) 2013, PATIENT WAS REVISED DUE TO BIO-MODULAR STEM LOOSENING. ALL BIOMET PRODUCTS WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323018 BIO-MOD ST.10X115 W/ALIGN HOLE PROSTHESIS, SHOULDER HSD BIOMET ORTHOPEDICS N/A 793640

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R