BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 1860170 · Received September 21, 2010

    Report

    Report Number
    1822565-2010-00755
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO PRODUCT WAS RETURNED FOR EVALUATION. ALSO, NO X-RAYS OR OPERATIVE NOTES WERE RETURNED FOR REVIEW. PATIENT INFORMATION SUCH AS HEIGHT, WEIGHT, AND ACTIVITY LEVEL IS UNKNOWN. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE ASCERTAINED AT THIS TIME. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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. 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 PROGRESSIVE RADIOLUCENT LINES AROUND THE FEMORAL COMPONENT ON RADIOGRAPHS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN NEXGEN LPS-FLEX FEMORAL COMPONENT KNEE PROSTHESIS HSA ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1