BEUDAMED
    FDA Adverse Event Summary report: N

    FOUNDATION

    MDR report key: 2990183 · Received March 5, 2013

    Report

    Report Number
    1644408-2013-00116
    Date Received
    March 5, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K993943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS DISLOCATION AFTER 39 DAYS OF PATIENT USE. 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 RECORDS SHOWED ONE NON-CONFORMING MATERIAL REPORT ASSOCIATED WITH THIS PRODUCT; ONE FOR A PRINT CHANGE AND THE OTHER FOR A DING. BOTH ITEMS WERE CONSIDERED ACCEPTABLE. (B)(4). THE ROOT CAUSE OF THE REVISION SURGERY WAS DUE TO DISLOCATION AND MOST LIKELY AS THE RESULT OF THE PATIENT FALLING. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT FELL CAUSING THE PROSTHESIS TO DISLOCATE. ALL OF THE HARDWARE WAS REMOVED DURING THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93014 FOUNDATION POROUS HA, PRESS FIT STEM SERIES 470 LPH ENCORE MEDICAL, L.P. 570C1008

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention 497-28-350, LOT 634C1010| 412-02-056, LOT 004C1011