BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPELAND HA SZ 2 RESURF HD

    MDR report key: 3162304 · Received June 11, 2013

    Report

    Report Number
    0001825034-2013-01900
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSD
    PMA / PMN Number
    PK010827
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE REASON FOR THE REVISION PROCEDURE, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES,"LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, NON-UNION, BONE RESORPTION, AND/OR EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A SHOULDER ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO STEM MALPOSITIONING. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A STEM, HEAD AND ADAPTER.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A SHOULDER ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO AN UNKNOWN REASON. THE RESURFACING HEAD WAS REMOVED AND REPLACED WITH A STEM, HEAD AND ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263239 COPELAND HA SZ 2 RESURF HD PROSTHESIS, SHOULDER HSD BIOMET ORTHOPEDICS N/A 332090

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R