BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP FX HUM POS SLEEVE 10MM

    MDR report key: 3201872 · Received July 2, 2013

    Report

    Report Number
    0001825034-2013-02435
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK033506
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." THIS REPORT IS NUMBER 3 OF 13 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-02433/02445).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL SHOULDER PROCEDURE (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED (B)(6) 2013, DUE TO INFECTION. REVIEW OF INVOICE HISTORY INDICATES UNKNOWN PROCEDURES WERE PERFORMED (B)(6) 2012 AND (B)(6) 2013. IT IS UNKNOWN IF THESE PROCEDURES WERE RELATED TO REPORTED EVENT. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301254 COMP FX HUM POS SLEEVE 10MM PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 254310

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R