BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR 8X28MM IMPL STEM W/SCR

    MDR report key: 7279681 · Received February 19, 2018

    Report

    Report Number
    0001825034-2018-00785
    Event Type
    Injury
    Date Received
    February 19, 2018
    Date of Event
    July 27, 2012
    Report Date
    February 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWI
    PMA / PMN Number
    PK040611
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-210033, EXPLOR 14X22MM IMPLANT HEAD, 792030. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 00784. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED THIS REPORTING IS A DUPLICATE OF (B)(4). THIS DEVICE WAS FOUND TO BE NOT REPORTABLE TO THIS EVENT. PLEASE VOID THIS SUBMISSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT ELBOW ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123493 EXPLOR 8X28MM IMPL STEM W/SCR PROSTHESIS, ELBOW KWI ZIMMER BIOMET, INC. N/A 839040

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R