BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 6301080 · Received February 3, 2017

    Report

    Report Number
    0001822565-2017-00442
    Event Type
    Injury
    Date Received
    February 3, 2017
    Report Date
    January 30, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    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

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. 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 2 PATIENTS EXPERIENCED PARTIAL RADIOLUCENT LINES WITHOUT MIGRATION OF THE COMPONENT. NO REVISION PROCEDURE HAS BEEN REPORTED AND PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84923 UNKNOWN HIP PROSTHESIS, HIP JDI ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other