BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX OPTION FEMORAL COMPONENT

    MDR report key: 3890764 · Received June 4, 2014

    Report

    Report Number
    1822565-2014-00697
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    January 9, 2013
    Report Date
    May 7, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNKNOWN. THE PACKAGE INSERT FOR THIS DEVICE LISTS PAIN AS A POTENTIAL ADVERSE EFFECT. COMPLAINT HISTORY SEARCH SHOWS NO OTHER REPORTS OF ANY NATURE RECEIVED FOR THIS LOT NUMBER. COMPATIBILITY OF THE UTILIZED IMPLANT CONSTRUCT WAS REVIEWED WITH NO ISSUES NOTED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE DEVICE HISTORY RECORDS WERE REVIEWED, AND INDICATE THE DEVICE WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327481 NEXGEN LPS-FLEX OPTION FEMORAL COMPONENT NJL ZIMMER, INC. 61429129

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention