BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOW HIP

    MDR report key: 6301077 · Received February 3, 2017

    Report

    Report Number
    0001822565-2017-00444
    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 A PATIENT EXPERIENCED OSTEOLYSIS AND A HARRIS HIP SCORE OF 76. NO REVISION HAS BEEN REPORTED TO DATE AND PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83445 UNKNOW HIP PROSTHESIS, HIP JDI ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other