BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCEED ABT E1 FLNG CUP 32X50MM

    MDR report key: 8423918 · Received March 15, 2019

    Report

    Report Number
    3002806535-2019-00284
    Event Type
    Injury
    Date Received
    March 15, 2019
    Date of Event
    October 20, 2016
    Report Date
    March 15, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: 32MM MOD HEAD COCR STD NECK, CATALOG #: 163669, LOT #: J3759494. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00285. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    HIP REVISION DUE TO DISLOCATION AND SUBLUXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219187 EXCEED ABT E1 FLNG CUP 32X50MM HIP PROSTHESIS JDI BIOMET UK LTD. N/A 3862507

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R