BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL FEMUR MIG

    MDR report key: 6010420 · Received October 7, 2016

    Report

    Report Number
    3004105610-2016-00088
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 13, 2016
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    N/A
    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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ACETABULAR WEAR INVOLVING A PROXIMAL FEMUR MIG WAS REPORTED. THERE IS NO INDICATION THAT THE REPORTED PATIENT ACETABULAR BONE WEAR IS DEVICE RELATED. THE EVENT WAS NOT CONFIRMED. THE SURGEON CANCELLED THE REVISION DEVICE PIN 20386 AND NO FURTHER INFORMATION HAS BEEN PROVIDED AS THE PATIENT'S CONDITION WAS CONSIDERED TO BE UNRELATED TO THE IMPLANTED DEVICE. THE PROXIMAL FEMUR MIG REMAINS IMPLANTED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. DURING REVIEW OF THE AVAILABLE INFORMATION BY THE DESIGN DEPARTMENT IT HAS BEEN REPORTED THAT THE PATIENT ACETABULAR BONE WEAR MAY BE RELATED TO PATIENT CONDITIONS. REQUESTS WERE MADE FOR FURTHER INFORMATION IN RELATION TO THIS INCIDENT HOWEVER THE REQUESTED INFORMATION WAS NOT PROVIDED TO STANMORE IMPLANTS WORLDWIDE (SIW). 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. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. SIW WILL CONTINUE TO MONITOR FOR TRENDS. PLEASE NOTE THAT UPON FURTHER INVESTIGATION, IT WAS CONFIRMED THAT THE DEVICE WHICH IS THE SUBJECT OF THIS COMPLAINT IS A PROXIMAL FEMUR MINIMALLY INVASIVE GROWER IMPLANT. THE PROXIMAL FEMUR MINIMALLY INVASIVE GROWER IMPLANT IS NOT MARKETED IN THE US, NOR IS A SIMILAR DEVICE MARKETED IN THE US.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PATIENT REQUIRES A REVISION OF THEIR PROXIMAL FEMORAL MIG IMPLANT DUE TO WEARING OF THE ACETABULAR COMPONENT. REF: (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PATIENT REQUIRES A REVISION OF THEIR PROXIMAL FEMORAL MIG IMPLANT DUE TO WEARING OF THE ACETABULAR COMPONENT. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2016-00088 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662899 PROXIMAL FEMUR MIG LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD PIN 11335 PIN 11335

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention