BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL HEAD W/BFH

    MDR report key: 2203126 · Received August 11, 2011

    Report

    Report Number
    1043534-2011-00406
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    March 30, 2011
    Report Date
    August 4, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K021349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO THE EVENT. PRODUCT NOT RETURNED FOR EVALUATION. NO CATALOG/LOT NUMBER WAS PROVIDED FOR QUALITY OR TRENDING REVIEW; HOWEVER, THERE ARE NO TRENDS FOR THE PRODUCT FAMILY. INCLUDED IN THE COMPLAINT INFORMATION IT WAS REPORTED THAT THE PATIENT DID NOT FOLLOW POST-OPERATIVE RECOMMENDATIONS FROM THE SURGEON. WITH THE CIRCUMSTANCES OF THE INCIDENT AND INFORMATION REGARDING THE NON-COMPLIANCE OF THE PATIENT, NO PRODUCT RELATED ISSUES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    DEVICE #2: INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00405. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) TOTAL HEAD W/BFH HIP COMPONENT KWA WRIGHT MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R