BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL FEMUR JTS

    MDR report key: 6106096 · Received November 16, 2016

    Report

    Report Number
    3004105610-2016-00101
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    October 17, 2016
    Report Date
    October 17, 2016
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K133152
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW PRESCRIPTION FOR A REVISION SURGERY HAS BEEN RECEIVED. THE DATE FOR THE REVISION SURGERY IS NOT YET KNOWN. FURTHER INFORMATION HAS BEEN REQUESTED FROM THE SURGEON IN ORDER TO PROCEED WITH THE INVESTIGATION. A SUPPLEMENTAL WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    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 SUCH AS PRODUCT DETAILS, PRODUCT RETURN, PRE- AND POST-OPERATIVE X-RAYS, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BIKE ACCIDENT RESULTING IN PERIPROSTHETIC FRACTURE. THE SURGEON HAS REQUESTED A TOTAL FEMORAL REPLACEMENT LEAVING THE DISTAL FEMORAL PART IN SITU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BIKE ACCIDENT RESULTING IN PERIPROSTHETIC FRACTURE. THE SURGEON HAS REQUESTED A TOTAL FEMORAL REPLACEMENT LEAVING THE DISTAL FEMORAL PART IN SITU. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2016-00101 ((B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757282 DISTAL FEMUR JTS LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD PIN 13566 PIN 13566

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention