BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM XL 44-36 STD HMRL BRNG

    MDR report key: 3031747 · Received April 2, 2013

    Report

    Report Number
    0001825034-2013-00840
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 9, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 9 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY OR EXCESSIVE ACTIVITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00840 / 00841).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT INITIAL REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO DISLOCATION. THE GLENOSPHERE HEAD AND BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133747 ARCOM XL 44-36 STD HMRL BRNG PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 462080

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R