BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCEED ABT E1 FLNG CUP 28X46MM

    MDR report key: 8522085 · Received April 17, 2019

    Report

    Report Number
    3002806535-2019-00371
    Event Type
    Injury
    Date Received
    April 17, 2019
    Date of Event
    December 22, 2017
    Report Date
    April 17, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDD
    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). REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: 28MM MOD HD STD NECK TP1 TAPER, CATALOG #: 163662, LOT #: 00J3536062, MEDICAL PRODUCT: ARCOS CON SZ A STD 80MM HA, CATALOG #:22-301341, LOT #: 488280. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00372. 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.

    Description of Event or Problem · 1

    HIP REVISION DUE TO DISLOCATION AND SUBLUXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315366 EXCEED ABT E1 FLNG CUP 28X46MM HIP PROSTHESIS JDD BIOMET UK LTD. N/A 3837697

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R