BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 6301685 · Received February 3, 2017

    Report

    Report Number
    0001822565-2017-00448
    Event Type
    Injury
    Date Received
    February 3, 2017
    Date of Event
    October 21, 2016
    Report Date
    April 26, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDG
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT WAS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS IDENTIFIED DURING REVIEW OF A JOURNAL ARTICLE: MATTHIEU OLLIVIER, ET AL. ¿USE OF POROUS TANTALUM COMPONENTS IN PAPROSKY TWO AND THREE ACETABULAR REVISION. A MINIMUM FIVE-YEAR FOLLOW-UP OF FIFT ONE HIPS.¿ 10.1007/S00264-016-3312-2.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT A PATIENT EXPERIENCED A REVISIONS DUE TO DEEP INFECTION THAT REQUIRED A LAVAGE WITH POLYETHYLENE AND HEAD EXCHANGE ON AN UNKNOWN DATE. NO FURTHER INFORMATION IS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82624 UNKNOWN HIP PROSTHESIS, HIP JDG ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R