BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN FEMORAL COMPONENT

    MDR report key: 6642962 · Received June 15, 2017

    Report

    Report Number
    0001822565-2017-04047
    Event Type
    Injury
    Date Received
    June 15, 2017
    Date of Event
    July 25, 2013
    Report Date
    June 14, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE ARTICLE WAS WRITTEN BY MARIANO FERNANDEZ-FAIREN, DANIEL HERNANDEZ-VAQUERO, ANTONIO MURCIA, ANA TORRES, RAFAEL LLOPIS. THE COMPLAINT DEVICE IS NOT EXPECTED FOR RETURN CURRENTLY, BUT A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION. FERNANDEZ-FAIREN, ET AL. " TRABECULAR METAL IN TOTAL KNEE ARTHROPLASTY ASSOCIATED WITH HIGHER KNEE SCORES: A RANDOMIZED" CLIN ORTHOP RELAT RES (2013) 471:3543¿3553. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS ARE UNKNOWN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE TWO PATIENTS HAD PROGRESSIVE RADIOLUCENT LINES UNDER THE ANTERIOR FLANGE OF THE FEMORAL COMPONENT AFTER A KNEE ARTHROPLASTY ON AN UNKNOWN DATE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425861 UNKNOWN NEXGEN FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other