BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STEM

    MDR report key: 6325210 · Received February 13, 2017

    Report

    Report Number
    0001822565-2017-00462
    Event Type
    Injury
    Date Received
    February 13, 2017
    Report Date
    January 31, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWA
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    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. THIS ARTICLE WAS AUTHORED BY JOHANNES C. REICHART, MAXIMILIAN R. VOLKMANN, MAXIMILIAN KOPPMAIR, LARS RACKWITZ, MARTIN LUDEMANN, MAXIMILIAN RUDERT, AND ULRICH NOTH. ¿COMPARITIVE RETROSPECTIVE STUDY OF THE DIRECT ANTERIOR AND TRANSGLUTEAL APPROACHES FOR PRIMARY TOTAL HIP ARTHROPLASTY¿ INTERNATIONAL ORTHOPAEDICS (SICOT) (2015) 39:2309-2313. THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 0001822565-2017-00459, 0001822565-2017-00460, 0001822565-2017-00461).

    Description of Event or Problem · 1

    AN UNKNOWN NUMBER OF PATIENTS IDENTIFIED IN A JOURNAL ARTICLE REPORTED PAIN POST-IMPLANTATION. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENTS' OUTCOMES ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109134 UNKNOWN STEM HIP PROSTHESIS KWA ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other