BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSYS PROVISIONAL FEMORAL HEAD

    MDR report key: 2903762 · Received January 4, 2013

    Report

    Report Number
    1822565-2013-00026
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    November 16, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. CAUSE CANNOT BE DEFINITIVELY DETERMINED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THIS INVESTIGATION CLOSED. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PROVISIONAL BROKE DURING USE. THE PIECES WERE REMOVED FROM THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4959 VERSYS PROVISIONAL FEMORAL HEAD LPH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1