BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX OPTION FEMORAL COMPONENT

    MDR report key: 3913123 · Received June 11, 2014

    Report

    Report Number
    1822565-2014-00740
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    July 10, 2012
    Report Date
    May 13, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPATABILITY WAS VERIFIED WITH NO ISSUES NOTED. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNK. OPERATIVE NOTES WERE NOT PROVIDED. RADIOGRAPHS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL CODES: DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343679 NEXGEN LPS-FLEX OPTION FEMORAL COMPONENT NJL ZIMMER, INC. 61523260

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE,| CATALOG#00596204014, LOT#61075209