BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL HEAD W/BFH

    MDR report key: 2761329 · Received September 26, 2012

    Report

    Report Number
    1043534-2012-01219
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    November 3, 2011
    Report Date
    September 11, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K021349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-01216, 01217, 01218. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALLEGEDLY ACCORDING TO THE PATIENT, EVERYTHING WAS FINE UNTIL HE SUSTAINED FALL WHILE PLAYING BADMINTON. HE FELL ON HIS LEFT HIP. FROM THAT POINT ON, THERE WAS PAIN. THE IMPLANT WAS REMOVED ON (B)(6) 2011 AND ONLY AFTER AN INFECTION WAS CONSIDERED TO HAVE BEEN ERADICATED. A NEW PROSTHESIS WAS IMPLANTED ON (B)(6) 2011. ALVAL WAS SEEN IN TISSUE SAMPLES. THE PATIENT HAS ALMOST MADE A COMPLETE RECOVERY AND IS STILL IMPROVING. HIGH ACTIVITY LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) TOTAL HEAD W/BFH HIP COMPONENT, CODE:KWA KWA WRIGHT MEDICAL TECHNOLOGY, INC. 049852498

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention