BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM SMILES TKR REPLACEMENT IMPLANT

    MDR report key: 6185619 · Received December 19, 2016

    Report

    Report Number
    3004105610-2016-00126
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K102992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER IT WAS NOT PROVIDED. THERE IS NO DOCUMENTED EVIDENCE THAT AN AXLE OR ANY OTHER COMPONENTS WERE REQUESTED FROM SIW PRIOR TO THE SURGERY. EVIDENCE INDICATES ONCE CONTACTED SIW PROVIDED AN AXLE IN AS TIMELY A MANNER AS POSSIBLE. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. STANMORE IMPLANTS WORLDWIDE WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEW EXTRA SMALL COMPONENTS FOR THE PATIENT HAD NOT BEEN ORDERED, DESPITE THE FACT THE PATIENT WAS LISTED AS "CUSTOM SMILES - REVISION BOLT AND REBUSHING - NEW BARREL AND CLIP". ALL POLY COMPONENTS WERE AVAILABLE FROM THE SPARES BOX KEPT AT THE HOSPITAL. THE PATIENT WAS MOVED TO 3RD ON THE LIST TO ALLOW TIME TO OBTAIN AN EXTRA SMALL AXLE FROM THE WORKSHOP. IT WAS POLISHED AND TAKEN IMMEDIATELY TO TSSU FOR STERILISATION. UNFORTUNATELY THE AXLE WAS NOT READY IN TIME FOR THE OPERATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838532 CUSTOM SMILES TKR REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD PIN 18820

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other