BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 2530347 · Received April 5, 2012

    Report

    Report Number
    1644408-2012-00166
    Event Type
    Other
    Date Received
    April 5, 2012
    Date of Event
    March 16, 2012
    Report Date
    March 16, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K973302
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS DISLOCATION AFTER 17 DAYS OF PATIENT USE. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REVISION SURGERY. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS REPORT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE SEVENTH COMPLAINT FOR THIS PART NUMBER: TWO DISLOCATION, TWO TRAUMA, ONE DISSOCIATION, ONE STABILITY/POOR FIT, AND ONE FIT ISSUES. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE DISLOCATION WAS NOT DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. SEVERAL FACTORS NOT RELATED TO THE IMPLANT CAN PLAY A ROLE IN DISLOCATION SUCH AS; LOOSE JOINT FROM INADEQUATE SOFT TISSUE, AND PATIENT ACTIVITY.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427150 FOUNDATION HIP POROUS, PRESS FIT STEM SERIES 470 LPH ENCORE MEDICAL, L.P. 563C1037

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention 497-28-000, LOT 629C1082