BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM XL 44-36 STD HUMERAL BEARING

    MDR report key: 3071459 · Received April 22, 2013

    Report

    Report Number
    0001825034-2013-01097
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 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
    MI, 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: "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY OR EXCESSIVE ACTIVITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, THE PATIENT'S CAREGIVER PULLED THE PATIENT UP BY THE ARMS WHEN THE PATIENT WAS IN A SITTING POSITION AND THE PATIENT'S SHOULDER DISLOCATED. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 AND THE HUMERAL TRAY AND BEARING WERE REMOVED AND REPLACED WITH LARGER SIZED COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171402 ARCOM XL 44-36 STD HUMERAL BEARING PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 817730

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R