BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR 8X28 MM IMPLANT STEM WITH SCREW

    MDR report key: 6537367 · Received May 2, 2017

    Report

    Report Number
    0001825034-2017-02965
    Event Type
    Injury
    Date Received
    May 2, 2017
    Report Date
    May 2, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWI
    PMA / PMN Number
    PK040611
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: EXPLOR 10X22 MM RADIAL HEAD, CAT#: 11-210031, LOT#: NI. (B)(6). HALVERSON ET AL. "CLINICAL OUTCOMES OF BIOMET EXPLOR MODULAR RADIAL HEAD ARTHROPLASTY SYSTEM" JOURNAL TITLE. 37:853-858. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS THE LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1825034-2017-02282, 02965.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THE PATIENT UNDERWENT A SUBSEQUENT ELBOW PROCEDURE APPROXIMATELY 26 MONTHS POST-IMPLANTATION FOR SEROMA EVACUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318591 EXPLOR 8X28 MM IMPLANT STEM WITH SCREW PROSTHESIS, ELBOW KWI BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention