BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR 8X28MM IMPL STEM W/SCR

    MDR report key: 6519257 · Received April 25, 2017

    Report

    Report Number
    0001825034-2017-02736
    Event Type
    Injury
    Date Received
    April 25, 2017
    Report Date
    April 25, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A1-CMP-0279289 E1 - INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY SCHUYLER J HALVERSON, MIHIR J DESAI AND DONALD H LEE. H3 - THE COMPLAINT DEVICE IS NOT EXPECTED FOR RETURN CURRENTLY, BUT A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION. HALVERSON ET AL. "CLINICAL OUTCOMES OF BIOMET EXPLOR MODULAR RADIAL HEAD ARTHROPLASTY SYSTEM" JOURNAL TITLE. 37:853-858. PG. 1-33. D11 - MEDICAL PRODUCTS - EXPLOR RADIAL HEAD: CATALOG #11-210043, LOT # NI 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.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THE PATIENT EXPERIENCED MILD ELBOW PAIN APPROXIMATELY 4 MONTHS POST-IMPLANTATION OF A RIGHT RADIAL HEAD ARTHROPLASTY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300673 EXPLOR 8X28MM IMPL STEM W/SCR PROSTHESIS, ELBOW KWI BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other SEE NARRATIVE IN H10