BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR 8X28MM IMPL STEM W/SCR

    MDR report key: 10643827 · Received October 7, 2020

    Report

    Report Number
    0001825034-2020-03709
    Event Type
    Injury
    Date Received
    October 7, 2020
    Date of Event
    January 23, 2019
    Report Date
    January 11, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWI
    PMA / PMN Number
    K040611
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENTS UNDER COMPLAINTS (B)(6), (B)(6), (B)(6), (B)(6), ARE A CONTINUATION OF THE SAME COMPLICATION RESISTANT TO MEDICAL/SURGICAL INTERVENTIONS, ARE WITHIN A SHORT TIMEFRAME, AND NO PRODUCT HAS BEEN EXCHANGED. THIS DEVICE HAS BEEN REPORTED UNDER (B)(6), AND MEDWATCH# 0001825034 - 2021 - 00058.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE HAS BEEN REPORTED AS A DUPLICATE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-210043 EXPLOR 14X24 MM IMPLANT HEAD 504020. 3322-020 DEPUY BONE CEMENT 8195909. FOREIGN REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. 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 - 2020 - 01260 - 2.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT ORIF, LATERAL LIGAMENT REPAIR, AND RADIAL HEAD REPLACEMENT. SUBSEQUENTLY, POST THREE SURGICAL INTERVENTIONS WITHIN TWO YEARS, THE PATIENT CONTINUES TO EXPERIENCE DIFFICULTY WITH STIFFNESS AND RANGE OF MOTION WITHOUT RELIEF. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105863 EXPLOR 8X28MM IMPL STEM W/SCR PROSTHESIS, ELBOW KWI ZIMMER BIOMET, INC. 561880

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SEE NARRATIVE IN H10.