BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR 9X30MM IMPL STEM W/SCREW

    MDR report key: 8678783 · Received June 7, 2019

    Report

    Report Number
    0001825034-2019-02275
    Event Type
    Injury
    Date Received
    June 7, 2019
    Date of Event
    May 15, 2019
    Report Date
    September 20, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWI
    PMA / PMN Number
    K051385
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. NO PRODUCT WAS RETURNED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: "OVERALL FIT APPEARS NORMAL, ALTHOUGH THERE IS A DISLODGED SCREW. ALIGNMENT IS NORMAL. BONE QUALITY APPEARS NORMAL. NO SIGNS OF LOOSENING, WEAR, RADIOLUCENCY, OR CONTRIBUTING FACTORS ARE DETECTED." THE COMPLAINT IS CONFIRMED. ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: RADIAL HEAD, 11-210043 WITH LOT NR 611770. REPORT SOURCE: FOREIGN- THE EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE EVALUATED BY MFR: DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED PAIN POST PROCEDURE. IT WAS IDENTIFIED THE SCREW BACKED OUT OF THE RADIAL HEAD. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. IT HAS NOT BEEN INDICATED THE PATIENT HAS BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471349 EXPLOR 9X30MM IMPL STEM W/SCREW PROSTHESIS, EXTREMITY KWI ZIMMER BIOMET, INC. N/A 424080

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R