BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXC ABT CMTD ARC ML CUP 28X50

    MDR report key: 7548658 · Received May 29, 2018

    Report

    Report Number
    3002806535-2018-00869
    Event Type
    Injury
    Date Received
    May 29, 2018
    Date of Event
    April 23, 2018
    Report Date
    September 13, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT INFORMATION AND THE DETAILS OF THE INITIAL SURGERY WERE CONFUSED WITH THE PATIENT¿S CONTRALATERAL HIP. THE REPORTED REVISION WAS THE LEFT HIP REVISION DUE TO BURSITIS. THE PRODUCT INFORMATION AND THE PRIMARY SURGERY DETAILS INITIALLY PROVIDED CONCERNED THE PATIENT¿S RIGHT HIP. FURTHER INFORMATION AND CLARIFICATION WAS REQUESTED FROM THE CLINICAL STUDY DEPARTMENT. UPON RECEIPT OF FURTHER CLARIFICATIONS FROM CLINICAL STUDY DEPARTMENT, WHO CONFIRMED THAT THE PATIENT UNDERWENT LEFT HIP REVISION SURGERY ONLY, COMPLAINT (B)(4) WAS DEEMED ¿NOT A COMPLAINT¿. NEW COMPLAINT, (B)(4), HAS BEEN CREATED TO ADDRESS LEFT HIP SURGERY.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO PRODUCT BEING DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET 28MM DIA COCR MOD HD -6MM NK, ITEM#163660, LOT# J3030610, REPORTED UNDER 0001825034 - 2018 - 03565. BIOMET MLRY-HD POR FMRL 11X160MM, ITEM#: 11-104111, LOT#: 070970.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION OF HEAD APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO BURSITIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392265 EXC ABT CMTD ARC ML CUP 28X50 HIP PROSTHESIS JDI BIOMET UK LTD. N/A 2705098

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R