BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER- STRAIGHT SHELL

    MDR report key: 4745747 · Received May 4, 2015

    Report

    Report Number
    3005985723-2015-00062
    Event Type
    Malfunction
    Date Received
    May 4, 2015
    Date of Event
    April 8, 2015
    Report Date
    April 8, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    OQG
    PMA / PMN Number
    K122158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED AND THE DEVICE NOT BEING RETURNED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    SURGEON TRIED USING 112710, LOT 120087 IMPACTOR SHAFT TO INSERT AND REMOVE A TRIAL SHELL. THIS INSTRUMENT HAD DAMAGED THREADS SO HE WAS NOT ABLE TO PROPERLY ASSESS THE REAMED ACETABULUM LIKE HE NORMALLY WOULD.

    Description of Event or Problem · 1

    SURGEON TRIED USING 112710, LOT 120087 IMPACTOR SHAFT TO INSERT AND REMOVE A TRIAL SHELL. THIS INSTRUMENT HAD DAMAGED THREADS SO HE WAS NOT ABLE TO PROPERLY ASSESS THE REAMED ACETABULUM LIKE HE NORMALLY WOULD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291249 INSERTER- STRAIGHT SHELL HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS, U OQG STRYKER ORTHOPAEDICS-MAHWAH 120087

    Patients

    Seq Age Sex Outcome Treatment
    1 Other