BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT SM SIZE 3 PMA

    MDR report key: 6971097 · Received October 24, 2017

    Report

    Report Number
    0001825034-2017-07432
    Event Type
    Injury
    Date Received
    October 24, 2017
    Date of Event
    June 17, 2015
    Report Date
    September 27, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: ITEM#141233 - LOT#J2897864 - ITEM NAME BIOMET CC CRUCIATE TRAY 71MM. ITEM#189068 - LOT#184590 - ITEM NAME VNGD ANT STBLZD BRG 18X71. ITEM#148305 - LOT#877160 - ITEM NAME BMT SPLINED KNEE STM V2 15X80. ITEM#185210 - LOT#950180 - ITEM NAME BMT 360 2.5MM OFFSET ADAPTER. ITEM#185210 - LOT#950170 - ITEM NAME BMT 360 2.5MM OFFSET ADAPTER. THERAPY DATE: (B)(6) 2015. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. PRODUCT WAS NOT RETURNED TO BIOMET FOR EVALUATION. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED. 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. RELAYED COMPLETION OF THE INVESTIGATION TO THE SALES REP VIA EMAIL ON SEPTEMBER 10, 2014. ALSO REQUESTED THE RESULTS BE RELAYED TO THE SURGEON. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2013 FOR UNKNOWN REASONS. SURGEON REMOVED AND REPLACED THE FEMORAL COMPONENT, TIBIAL TRAY, AND BEARING. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753352 OXF ANAT BRG RT SM SIZE 3 PMA PROSTHESIS-KNEE JWH ZIMMER BIOMET, INC. NI 2648149

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention