BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP 6MM HUM FRAC STEM MACRO

    MDR report key: 2895094 · Received January 3, 2013

    Report

    Report Number
    0001825034-2013-00005
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 10, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWT
    PMA / PMN Number
    PK023063
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 2 OF 10 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00004 / 00013).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A COMPREHENSIVE REVERSE SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012 DUE TO AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3290 COMP 6MM HUM FRAC STEM MACRO PROSTHESIS, SHOULDER KWT BIOMET ORTHOPEDICS N/A 781450

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R