BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS HEAD

    MDR report key: 3070529 · Received April 22, 2013

    Report

    Report Number
    1043534-2013-00675
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    April 27, 2011
    Report Date
    March 13, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT AND PACKAGE INSERT WERE REVIEWED. THE PRODUCT WAS NOT RETURNED. (B)(4): EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODES ARE ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2013-00674, 00676, 00677.

    Description of Event or Problem · 1

    ALLEGEDLY PT. SUFFERED THE FOLLOWING: PERSISTENT, DEBILITATING RIGHT HIP AND GROIN PAIN, INFECTION DUE TO METALLOSIS. RIGHT HIP ASPIRATION PROCEDURE ON (B)(6) 2011 DUE TO INFECTION FROM METALLOSIS. EXPLANT RIGHT HIP ON (B)(6) 2011 AND PLACEMENT OF ANTIBIOTIC SPACER. IV ANTIBIOTICS FOR 6 WKS. RIGHT HIP REVISION SURGERY (B)(6) 2011. PROLONGED PAINFUL REHABILITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172630 CONSERVE(R) TOTAL A-CLASS HEAD HIP COMPONENT, CODE:JDL JDL WRIGHT MEDICAL TECHNOLOGY, INC. 058592689

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention