BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT LG SIZE 5 PMA

    MDR report key: 7120383 · Received December 15, 2017

    Report

    Report Number
    3002806535-2017-01207
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    July 11, 2017
    Report Date
    May 8, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    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). CONCOMITANT MEDICAL PRODUCTS: OXF UNI CMNTLS TIB SZ F RM, ITEM NO: 166581, LOT NO: 3840645, OXFORD PH3 CEMENTLESS FEM SZ L, ITEM NO: 154927, LOT NO: 3890293. 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: 3002806535-2017-01205, 3002806535-2017-01207.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED. 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. 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 · 1

    IT HAS BEEN REPORTED BY THE HOSPITAL THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE REPLACEMENT SURGERY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902488 OXF ANAT BRG RT LG SIZE 5 PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 3841191

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R