BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN STEM

    MDR report key: 6325212 · Received February 13, 2017

    Report

    Report Number
    0001822565-2017-00457
    Event Type
    Malfunction
    Date Received
    February 13, 2017
    Report Date
    January 31, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDG
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. INITIAL REPORTER - THIS ARTICLE WAS AUTHORED BY JOHANNES C. REICHART, MAXIMILIAN R. VOLKMANN, MAXIMILIAN KOPPMAIR, LARS RACKWITZ, MARTIN LUDEMANN, MAXIMILIAN RUDERT, AND ULRICH NOTH. ¿COMPARATIVE RETROSPECTIVE STUDY OF THE DIRECT ANTERIOR AND TRANSGLUTEAL APPROACHES FOR PRIMARY TOTAL HIP ARTHROPLASTY¿ INTERNATIONAL ORTHOPAEDICS (SICOT) (2015) 39:2309-2313.

    Description of Event or Problem · 1

    AN UNKNOWN NUMBER OF PATIENTS IDENTIFIED IN THE ARTICLE HAD STEM MALALIGNMENT. NO REVISIONS HAVE BEEN REPORTED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109072 UNKNOWN STEM HIP PROSTHESIS JDG ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1