BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS POROUS FEMORAL COMPONENT

    MDR report key: 3040024 · Received April 3, 2013

    Report

    Report Number
    1822565-2013-00598
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SURGICAL REPORTS WERE NOT PROVIDED. AN X-RAY IMAGE WAS RECEIVED, EXHIBITING A RADIOLUCENCY AROUND THE FEMUR. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. THE REPORTED RADIOLUCENCY AND LOOSE FEMUR ARE CONFIRMED; HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION CODES: THE MEASURE DIMENSIONS OF THE DEVICE WERE WITHIN SPECIFICATION AS RETURNED. A FEW SPOTS OF BIOLOGICAL MATERIAL WERE ADHERED TO THE DEVICE. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN, AND X-RAYS REVEALED EVIDENCE OF A RADIOLUCENT LINE AROUND THE FEMUR. A REVISION WAS PERFORMED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135609 NEXGEN LPS POROUS FEMORAL COMPONENT JWH ZIMMER, INC. 60891110

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention