BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN NEXGEN BEARING

    MDR report key: 6642957 · Received June 15, 2017

    Report

    Report Number
    0001822565-2017-04099
    Event Type
    Death
    Date Received
    June 15, 2017
    Date of Event
    July 25, 2013
    Report Date
    June 15, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). OUTCOMES ATTRIBUTED TO ADVERSE EVENTS ¿ NI. INITIAL REPORTER - 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2017-04101 AND 0001822565-2017-04102.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT 1 PATIENT DIED DUE TO UNKNOWN REASONS WITH IMPLANTS IN SITU AFTER A KNEE ARTHROPLASTY ON AN UNKNOWN DATE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425730 UNKNOWN NEXGEN BEARING PROSTHESIS, KNEE JWH ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death