BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR 6X24MM IMPL STEM W/SCR

    MDR report key: 6519367 · Received April 25, 2017

    Report

    Report Number
    0001825034-2017-02807
    Event Type
    Injury
    Date Received
    April 25, 2017
    Report Date
    April 25, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWI
    PMA / PMN Number
    PK051385
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - EXPLOR RADIAL HEAD: CATALOG # 11-210033, LOT # NI. (B)(6). HALVERSON ET AL. "CLINICAL OUTCOMES OF BIOMET EXPLOR MODULAR RADIAL HEAD ARTHROPLASTY SYSTEM" JOURNAL TITLE. 37:853-858. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS THE LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1825034-2017-02379.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THE PATIENT EXPERIENCED RADIOGRAPHIC LUCENCY AND MILD ELBOW PAIN APPROXIMATELY 92 MONTHS POST-IMPLANTATION OF A RADIAL HEAD ARTHROPLASTY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301682 EXPLOR 6X24MM IMPL STEM W/SCR PROSTHESIS, ELBOW KWI BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other