BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REF SPHER HEAD SCREW 25MM

    MDR report key: 8478665 · Received April 3, 2019

    Report

    Report Number
    1020279-2019-01345
    Event Type
    Injury
    Date Received
    April 3, 2019
    Date of Event
    November 29, 2018
    Report Date
    April 15, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MEH
    UDI-DI
    03596010460462
    PMA / PMN Number
    K990666
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THE NEW INFORMATION STATES THAT THIS IS A DUPLICATE OF THE CASE C-0223414, RELATED TO A NANOS STEM, MANUFACTURED BY THIRD PARTY MANUFACTURER OHST MEDIZINTECHNIK AG. THIS PRODUCT IS MANUFACTURED BY OHST MEDIZINTECHNIK AG RATHENOW AND LOCALLY DISTRIBUTED BY SMITH & NEPHEW GMBH MARL. THE INVESTIGATION ACTIVITIES HAS BEEN CONDUCTED BY SMITH & NEPHEW GMBH MARL ACCORDING TO LOCAL PROCEDURE., THEREFORE, IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS CARRIED OUT FOR A HIP PROSTHESIS EXCHANGE DUE TO IT BROKE AT THE SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270973 REF SPHER HEAD SCREW 25MM PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE MEH SMITH & NEPHEW, INC. 10LT01071 03596010460462

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R