BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUNDATION HIP

    MDR report key: 3900808 · Received June 27, 2014

    Report

    Report Number
    1644408-2014-00398
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K973302
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THE REVISION SURGERY IS IDENTIFIED AS LOOSENING OF THE STEM AND WAS BEGINNING TO SUBSIDE AFTER APPROXIMATELY 15 YEARS OF PATIENT USE. EXTENDED SEARCHES OF THE PATIENT DATABASE PRODUCED NO ADDITIONAL INFORMATION CONCERNING THE ORIGINAL SURGERY DATE. THERE IS NO INFORMATION SUPPLIED ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THIS REVISION. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE PRODUCT DEVICE HISTORY RECORDS WAS NOT CONDUCTED SINCE THE LOT NUMBER WAS NOT REPORTED FOR THIS EVENT AND COULD NOT BE ESTABLISHED OR DETERMINED. EXTENDED SEARCHES OF THE PATIENT DATABASE PRODUCED NO ADDITIONAL INFORMATION OR FURTHER IDENTIFIED THE SPECIFIC IDENTITY OF THE PRODUCT. THE ROOT CAUSE FOR THIS REVISION SURGERY WAS IDENTIFIED AS LOOSENING OF STEM AND THE STEM BEGAN TO SUBSIDE. WITHOUT ADDITIONAL INFORMATION THE CAUSE OF THE PRODUCT COMPLAINT WEAR CANNOT BE DETERMINED WITH CONFIDENCE OTHER THAN NORMAL USE. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE STEM LOOSENING; IT BEGAN TO SUBSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377890 FOUNDATION HIP FOUNDATION POROUS, PRESS FIT STEM SERIES 470 15MM LPH ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 497-28-350| 431-28-209