BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM XL 44-36 STD HUMERAL BEARING

    MDR report key: 3143049 · Received June 3, 2013

    Report

    Report Number
    0001825034-2013-01785
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    April 30, 2013
    Report Date
    September 18, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 THIS EVENT (REFERENCE 1825034-2013-01785/01786.)

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL SHOULDER ARTHROPLASTY (B)(6) 2011. A SUBSEQUENT REVISION WAS PERFORMED (B)(6) 2013 DUE TO DISLOCATION AND INSTABILITY. THE HUMERAL BEARING, ADAPTOR AND GLENOSPHERE WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244126 ARCOM XL 44-36 STD HUMERAL BEARING PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 418650

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R