BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 6928628 · Received October 9, 2017

    Report

    Report Number
    0001825034-2017-08139
    Event Type
    Injury
    Date Received
    October 9, 2017
    Report Date
    October 6, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    NRA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LOMBARDI JR., A. V.; BEREND,, K. R.; ADAMS, J. B. (2014) THE REVISION KNEE ARTHROPLASTY WHY KNEE REPLACEMENTS FAIL IN 2013 - PATIENT, SURGEON, OR IMPLANT? JOINT IMPLANT SURGEONS, NEW ALBANY, OHIO, UNITED STATES, JOINT IMPLANT SURGEONS, 7277, SMITH¿S MILL ROAD, SUITE 200, NEW ALBANY, OHIO, 43054, USA. CORRESPONDENCE SHOULD BE SENT TO DR A. V. LOMBARDI JR; E-MAIL: [email protected] ©2014 THE BRITISH EDITORIAL, SOCIETY OF BONE & JOINT, SURGERY, DOI:10.1302/0301-620X.96B11. (B)(4). THE PRODUCT WAS NOT AVAILABLE FOR RETURN. CONDITION IS ADDRESSED IN THE PACKAGE INSERT. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT DEVICE, ROOT CAUSE CANNOT BE DETERMINED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY, NEITHER WERE 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. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "WHY KNEE REPLACEMENTS FAIL IN 2013¿. IT WAS NOTED IN THE ARTICLE THAT AN UNKNOWN NUMBER OF PATIENT(S) EXPERIENCED INSTABILITY AND REQUIRED REVISION SURGERY. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712683 UNKNOWN KNEE PROSTHESIS - KNEE NRA ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R