BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM MOD HEAD COCR +3MM NECK

    MDR report key: 7027568 · Received November 14, 2017

    Report

    Report Number
    3002806535-2017-00956
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    June 14, 2015
    Report Date
    January 9, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 3002806535 - 2017 - 00955, 3002806535 - 2017 - 00956. CONCOMITANT MEDICAL PRODUCTS: ACETABULAR CUP, UNKNOWN PART/LOT, FEMORAL HEAD,UNKNOWN PART/LOT, FEMORAL STEM,UNKNOWN PART/LOT. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). CONCOMITANT MEDICAL PRODUCTS: EXC ABT CMTD ARC ML CUP 32X56, ITEM AR-123526, LOT 2726211- REMAINS IMPLANTED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM 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. MULTIPLE MDR'S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 3002806535 - 2017 - 00955-1.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A SINGLE RIGHT HIP DISLOCATION EVENT TREATED WITH A CLOSED REDUCTION. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809062 32MM MOD HEAD COCR +3MM NECK PROSTHESIS, HIP JDI BIOMET UK LTD. N/A 00J3402290

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R