BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM MID-SHAFT FEMUR

    MDR report key: 4361065 · Received December 19, 2014

    Report

    Report Number
    3004105610-2014-00105
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    September 8, 2013
    Report Date
    September 8, 2013
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. FROM FURTHER CORRESPONDENCE WITH THE SURGEON HE IS OF THE OPINION THAT AN IMPLANT OF THIS NATURE IS LIKELY TO LOOSEN DUE TO THE PATIENT'S CONDITION. REQUESTS ARE BEING MADE FOR ADDITIONAL INFORMATION AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT SUCCESSFUL REVISION SURGERY RESULTING IN THE IMPLANTATION OF A NEW TOTAL FEMUR. THE ASEPTIC LOOSENING OF THE ORIGINAL IMPLANT IS ATTRIBUTED TO PROGRESSIVE RENAL METASTASIS, AFTER TWO YEARS IN-SITU. ADDITIONAL INFORMATION AND PRODUCT RETURN WERE REQUESTED HOWEVER IT WAS NOT PROVIDED. FURTHER INFORMATION SUCH AS PRODUCT RETURN, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION. REVISION SURGERY WAS COMPLETED WITH NO REPORTED COMPLICATIONS. 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. NOTE: THIS DEVICE IS NOT MARKETED IN THE US BUT AN INITIAL MDR WAS FILED IN ERROR IN DECEMBER 2014, THEREFORE A SUPPLEMENTAL IS NOW BEING FILED FOLLOWING CONCLUSION OF THE INVESTIGATION. CORRECTIONS: (B)(6). PRODUCT NAME CORRECTED FROM CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT TO CUSTOM MID-SHAFT FEMUR. COMMON DEVICE NAME CORRECTED FROM PROSTHESIS, KNEE, FEMOROTIBIAL, CONS TO LIMB SALVAGE SYSTEM. MANUFACTURE DATE CORRECTED FROM 11/13 TO 10/04/2012.

    Description of Event or Problem · 1

    A SURGEON HAS REPORTED THAT A REVISION PROCEDURE IS REQUIRED FOR A PATIENT'S CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT DUE TO LOOSENING OF THE MID-SHAFT FEMORAL COMPONENT. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00105 ((B)(4)).

    Description of Event or Problem · 1

    A SURGEON HAS REPORTED THAT A REVISION PROCEDURE IS REQUIRED FOR A PATIENT'S CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT DUE TO LOOSENING OF THE MID-SHAFT FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837851 CUSTOM MID-SHAFT FEMUR LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME17427

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R