BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYN POR FEM COMP SZ 17

    MDR report key: 7052730 · Received November 22, 2017

    Report

    Report Number
    1020279-2017-01088
    Event Type
    Injury
    Date Received
    November 22, 2017
    Date of Event
    December 8, 2010
    Report Date
    January 17, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LPH
    PMA / PMN Number
    K963509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING REVIEW OF ALL DOCUMENTS RECEIVED IN REGARDS TO THIS EVENT WE HAVE IDENTIFIED AN ERROR IN INFORMATION PREVIOUSLY COMMUNICATED TO US, WHICH LED TO OUR CORRECTION IN FIELD OF THIS REPORT. FURTHERMORE THIS REVIEW IDENTIFIED THAT EVENT COMMUNICATED THROUGH THIS REPORT HAS PREVIOUSLY BEEN REPORTED TO YOU THROUGH MDR 1020279-2012-00198. FOR THIS REASON WE WILL CLOSE COMPLAINT FILE ASSOCIATED WITH MDR 1020279-2017-01088 AND WILL RE-OPEN THE INVESTIGATION ON THE COMPLAINT FILE ASSOCIATED WITH MDR 1020279-2012-00198. WE KINDLY ASK YOU TO DISREGARD MDR 1020279-2017-01088.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION OF TOTAL HIP WITH REPLACEMENT OF ALL COMPONENTS DUE TO SUBSIDENCE OF THE FEMUR COMPONENT. REMOVED WERE FEMORAL HEAD, FEMORAL STEM, ACETABULAR CUP, TAPER SLEEVE, ACETABULAR LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833008 SYN POR FEM COMP SZ 17 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH SMITH & NEPHEW, INC. 10EM15006

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R