BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4373106 · Received December 24, 2014

    Report

    Report Number
    3004105610-2014-00208
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K121056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING HISTORY CONFIRMS NO NON-CONFORMANCES WERE IDENTIFIED. THE SURGEON COMMENTED THAT THE PROSTHESIS HAD WORKED AND ALLOWED THE BONE TO CONTINUE TO GROW AT THE GROWTH PLATE. AS A RESULT THE PATIENT HAS BECOME MORE ACTIVE AND HE BELIEVES THAT THIS IS RELATED TO THE FRACTURE. REQUESTS ARE BEING MADE FOR ADDITIONAL INFORMATION AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFORMATION IS RECEIVED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR PROXIMAL FEMUR IMPLANT (K121056).

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. AN X-RAY REVIEW CONFIRMED THE REPORTED BONE FRACTURE AT THE FEMORAL STEM TIP. THERE IS NO INDICATION THAT, ON THE IMAGING PROVIDED, THE OBSERVED BONE FRACTURE WAS DEVICE RELATED AS NO DEVICE OR MANUFACTURING RELATED ISSUES CAN BE SEEN. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. REQUESTS WERE MADE FOR FURTHER INFORMATION IN RELATION TO THIS INCIDENT HOWEVER THE REQUESTED INFORMATION WAS NOT PROVIDED TO STANMORE IMPLANTS (SIW). FURTHER INFORMATION SUCH AS PRODUCT RETURN, 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. HOWEVER THE DEVICE WAS IN-SITU FOR 5 YEARS AND THE OBSERVED BONE FRACTURE COULD BE AS A RESULT OF THE PATIENT OUTGROWING THE IMPLANT WHICH WAS DESIGNED FOR THIS PATIENT IN 2009 AND THE SURGEON HAS INDICATED THAT THE PATIENT HAS GROWN SIGNIFICANTLY IN THAT TIME. ALSO THE PROSTHESIS HAS WORKED AND ALLOWED THE BONE TO CONTINUE TO GROW AT THE GROWTH PLATE. AS A RESULT THE PATIENT HAS BECOME MORE ACTIVE AND HE BELIEVES THAT THIS IS RELATED TO THE FRACTURE. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. THE COMPLAINT IS BEING CLOSED AND TRACKED AND TRENDED. COMMON DEVICE NAME/PRODUCT CODE WAS CORRECTED FROM "PROXIMAL FEMUR IMPLANT" TO "LIMB SALVAGE SYSTEM/KRO".

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SURGEON THAT THE PATIENT REQUIRES A REVISION PROCEDURE DUE TO A FRACTURE OF THE COMPONENT. THE SURGEON COMMENTED THAT THE PATIENT IS VERY ACTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SURGEON THAT THE PATIENT REQUIRES A REVISION PROCEDURE DUE TO A FRACTURE OF THE COMPONENT. THE SURGEON COMMENTED THAT THE PATIENT IS VERY ACTIVE. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00208 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851428 CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME14641

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention