BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SPECIFIC DISTAL FEMORAL

    MDR report key: 6184779 · Received December 19, 2016

    Report

    Report Number
    3004105610-2016-00125
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    July 20, 2013
    Report Date
    July 20, 2013
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K140898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REBUSHING IS AN ANTICIPATED EVENT OVER THE LIFETIME OF AN ORTHOPAEDIC IMPLANT, CONSISTING OF THE REPLACEMENT OF COMPONENTS WHICH ARE SUSCEPTIBLE TO WEAR. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION AND PRODUCT RETURN WERE REQUESTED HOWEVER IT WAS NOT PROVIDED. FURTHER INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. 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. THIS COMPLAINT FILE WAS REVIEWED AS PART OF SIW COMPLAINT FILE REMEDIATION PROGRAMME AND IT HAS BEEN DETERMINED THAT AN MDR SHOULD BE FILED. THIS COMPLAINT WAS RECEIVED BY SIW (B)(6) 2013.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A DEVICE IMPLANTED IN 1996 REQUIRED REBUSHING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838138 PATIENT SPECIFIC DISTAL FEMORAL LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD PIN 4269 PIN 4269

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization