BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 6968363 · Received October 23, 2017

    Report

    Report Number
    0001825034-2017-09571
    Event Type
    Injury
    Date Received
    October 23, 2017
    Report Date
    October 23, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    NRA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). VORLAT, P., PUTZEYS, G., COTTENIE, D., ISACKER, T. V., POULIART, N., HANDELBERG, F., . . . VERDONK, R. (2005, MAY 14). THE OXFORD UNICOMPARTMENTAL KNEE PROSTHESIS: AN INDEPENDENT 10-YEAR SURVIVAL ANALYSIS. RETRIEVED OCTOBER 23, 2017, FROM HTTPS://LINK.SPRINGER.COM/ARTICLE/10.1007/S00167-005-0621-1 THE PRODUCT WAS NOT AVAILABLE FOR RETURN. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY, NEITHER WERE PROVIDED. AS A PART OF DESIGN CONTROL RISK MANAGEMENT, CONDITION IS ADDRESSED THROUGH THE WARNINGS IN PACKAGE INSERT. 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

    ONE PATIENT WAS IDENTIFIED IN THE ARTICLE AND HAD TO BE REVISED TO A TKA 6 YEARS AFTER THE AUGMENTATION. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED. ALL OTHER EVENTS WILL BE REPORTED IN INDIVIDUAL RECORDS WHICH WILL BE LINKED TO THIS PARENT RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748143 UNKNOWN KNEE PROSTHESIS - KNEE NRA ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R