BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXF ANAT BRG RT LG SIZE 3 PMA

    MDR report key: 7534963 · Received May 22, 2018

    Report

    Report Number
    3002806535-2018-00855
    Event Type
    Death
    Date Received
    May 22, 2018
    Date of Event
    December 8, 2016
    Report Date
    June 5, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HRY
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - OXFORD PH3 CEMENTLESS FEM SZ L PC/HA , ITEM 154927, LOT 2062400, THERAPY DATE - UNKNOWN, OXFORD UNI TIB BRG MED SZ4, ITEM 154627, LOT 2037328, THERAPY DATE - UNKNOWN. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2018-00853 AND 3002806535-2018-00854.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO WAS PART OF A CLINICAL STUDY DIED . TO THE BEST OF THE SITE¿S KNOWLEDGE THE IMPLANTS REMAINED IN SITU AT THE TIME OF DEATH. THE CAUSE OF PATIENT¿S DEATH IS UNKNOWN. IF THE SITE KNEW THAT THE PATIENT'S DEATH WAS DEVICE-RELATED, THIS WOULD BE INDICATED IN THE ADVERSE EVENT FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377512 OXF ANAT BRG RT LG SIZE 3 PMA HRY BIOMET UK LTD. N/A 1531834

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death