BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CUP INSERTER

    MDR report key: 7610038 · Received June 18, 2018

    Report

    Report Number
    0001825034-2018-03960
    Event Type
    Injury
    Date Received
    June 18, 2018
    Date of Event
    May 21, 2018
    Report Date
    June 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 110010246, CUP, LOT # 6192122. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03959, 0001825034-2018-03960.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACETABULAR CUP BECAME STUCK ON THREADED SHAFT UPON INSERTION. THE CUP HAD TO BE EXPLANTED DUE TO MALFUNCTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452193 UNKNOWN CUP INSERTER HIP INSTRUMENTATION JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention