BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX OPTION FEMORAL COMPONENT

    MDR report key: 4142792 · Received September 23, 2014

    Report

    Report Number
    3007963827-2014-00047
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 16, 2013
    Report Date
    August 25, 2014
    Manufacturer
    ZIMMER ORTHOPEDIC MFG LTD
    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. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION CODES: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND IT APPEARS THAT THE LOTS IN QUESTION WERE PRODUCED, INSPECTED, AND PACKAGED WITHIN ESTABLISHED AND VALIDATED PROCESS PARAMETERS. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. 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.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591053 NEXGEN LPS-FLEX OPTION FEMORAL COMPONENT NJL ZIMMER ORTHOPEDIC MFG LTD 62096002

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention