BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR 18X24 MM IMPLANT HEAD

    MDR report key: 10244858 · Received July 8, 2020

    Report

    Report Number
    0001825034-2020-02669
    Event Type
    Injury
    Date Received
    July 8, 2020
    Date of Event
    January 28, 2020
    Report Date
    July 7, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWI
    PMA / PMN Number
    K051385
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-00740. CONCOMITANT MEDICAL PRODUCTS: PART# 11-210061 LOT# 479750. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS WERE NOT PROVIDED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT 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 · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT ELBOW PROCEDURE APPROXIMATELY TWELVE (12) YEARS AGO. SUBSEQUENTLY, PATIENT WAS REVISED APPROXIMATELY SIX (6) MONTHS AGO AND CONVERTED TO A TOTAL ELBOW DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709127 EXPLOR 18X24 MM IMPLANT HEAD PROSTHESIS, EXTREMITIES KWI ZIMMER BIOMET, INC. NI 949220

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R