BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    MDR report key: 2080674 · Received April 26, 2011

    Report

    Report Number
    1822565-2011-01029
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A USER FACILITY WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. (B)(4). EVALUATION SUMMARY: THIS FAILURE IS NOT THE RESULT OF THE DEVICE OR PACKAGING MATERIAL. IT APPEARS TO BE SURGICAL ERROR. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE RE-OPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A LEFT FEMORAL COMPONENT WAS IMPLANTED IN THE RIGHT KNEE OF THE PATIENT. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM TO HAVE THE CORRECT DEVICE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX GSF FEMORAL COMPONENT JWH ZIMMER, INC. 60856719

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention