BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM 12/14 TPR FEM HD STD NK

    MDR report key: 7827256 · Received August 29, 2018

    Report

    Report Number
    3002806535-2018-01035
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    September 20, 2017
    Report Date
    February 1, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE EVENT 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 · 0

    IT WAS REPORTED BY THE NJR THAT A PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY AND SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO INFECTION.

    Additional Manufacturer Narrative · 1

    (B)(4). UDI - (B)(4). MEDICAL PRODUCT - EXCEED ABT 3HL SHELL 48/60MM , ITEM 124860, LOT 3200549; THERAPY DATE - (B)(6) 2017; OLYMPIA STEM SIZE 5 RIGHT, ITEM 650-0635, LOT 3220851; THERAPY DATE - (B)(6) 2017. 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: 3002806535-2018-01034 AND 3002806535-2018-01036.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE NJR THAT A PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY AND SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669381 36MM 12/14 TPR FEM HD STD NK LPH BIOMET UK LTD. 3882226

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R