BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT

    MDR report key: 5653012 · Received May 13, 2016

    Report

    Report Number
    3004105610-2016-00032
    Event Type
    Malfunction
    Date Received
    May 13, 2016
    Date of Event
    April 12, 2016
    Report Date
    April 13, 2016
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENTATION KIT WAS RETURNED TO STANMORE IMPLANTS. A PRELIMINARY INVESTIGATION HAS CONFIRMED THAT A STANDARD SIZE BUSH COMPRESSOR WAS PROVIDED IN A SMALL SIZED CUSTOM INSTRUMENT TRAY. ALL CUSTOM INSTRUMENT TRAYS HAVE BEEN QUARANTINED AND ARE UNDERGOING INSPECTION. THE INVESTIGATION OF THIS COMPLAINT IS ONGOING. A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    FOLLOWING THE REPORTED EVENT, ALL IN-STOCK KITS WERE QUARANTINED FOR RE-INSPECTION. THE RESULTS REVEALED THAT THE INSTRUMENT TRAY (SMBI-KSM20) WHICH WAS THE SUBJECT OF THE COMPLAINT WAS THE ONLY INSTRUMENT TRAY CONTAINING AN INCORRECTLY SIZED BUSH COMPRESSOR. DEPENDING UPON THE SPECIFIC NATURE OF THE SURGERY BEING SCHEDULED, THE INSTRUMENT KIT MAY REQUIRE SOME MINOR MODIFICATION. IN THE SPECIFIC CASE SCHEDULED IN IRELAND, A SMALL SIZED BUSH COMPRESSOR WAS REQUIRED IN INSTRUMENT TRAY # SMBI-KSM20. HOWEVER, INSTEAD THE TRAY CONTAINED A STANDARD SIZED BUSH COMPRESSOR, WHICH WAS NOT IDENTIFIED DURING THE FINAL INSPECTION STAGE OF THE PROCESS. AS A RESULT, THE STANDARD SIZED BUSH COMPRESSOR WAS SHIPPED WITH THE CUSTOM TOTAL KNEE REPLACEMENT ORDER. THE INSPECTOR HAS SINCE UNDERGONE RETRAINING. THE COMPLAINT INVESTIGATION HAS CONCLUDED THAT THIS IS AN ISOLATED EVENT. RETRAINING OF THE INSPECTOR HAS BEEN COMPLETED. THIS IS CONSIDERED TO BE AN ISOLATED INCIDENT; THIS COMPLAINT INVESTIGATION IS COMPLETED AND IS BEING TRACKED AND TRENDED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE INSTRUMENT KIT PROVIDED FOR A SMALL CUSTOM CASE CONTAINED A STANDARD SIZED BUSH COMPRESSOR IN THE INSTRUMENT TRAY. THE IMPLANT PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. (B)(4).

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2016-00032 (SIW-16-1426).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308803 PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD PIN 20084 PIN 20084

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other