BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METS DISTAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4905169 · Received July 8, 2015

    Report

    Report Number
    3004105610-2015-00062
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    January 1, 2015
    Report Date
    June 8, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    PMA / PMN Number
    K120992
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING HISTORY RECORDS HAS BEEN CARRIED OUT AND IT WAS CONFIRMED THAT THE DEVICE WAS MANUFACTURED WITHIN SPECIFICATION WITH NO ABNORMALITIES OR DEVIATIONS. THE SURGEON REPORTED THAT THE CIRCLIP HAD BROKEN, HOWEVER IT WAS DISPOSED OF BY THE HOSPITAL AND THUS IS UNAVAILABLE FOR EVALUATION. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE REPORTED BROKEN "CIRCLIP." PER THE SURGICAL TECHNIQUE, THE "CIRCLIP" COMPONENT IS DESIGNED TO BE IMPLANTED USING "CIRCLIP" PLIERS SUPPLIED IN STANMORE'S INSTRUMENTATION KIT. THE DEVICE SURGICAL TECHNIQUE (SECTION 3.10.2 "USE OF CIRCLIP PLIERS") PROVIDES DETAILED INSTRUCTIONS/PHOTOS OF A PROPERLY INSERTED CIRCLIP, AS WELL AS AN INCORRECTLY INSERTED 'CIRCLIP". PLEASE NOTE THAT ONE POSSIBILITY FOR DISENGAGEMENT OR FRACTURE OF THE "CIRCLIP" IS DUE TO AN INCORRECTLY IMPLANTED "CIRCLIP." THIS EVENT WILL BE TRACKED AND TRENDED. IF ANY ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE SURGEON REPORTED TO THE COMPANY SALES REPRESENTATIVE THAT THE PATIENT WAS UNDERGOING A REVISION OF HER METS DISTAL FEMUR REPLACEMENT IMPLANT DUE TO A BROKEN "CIRCLIP." NOTE THAT THE "CIRCLIP" IS A DEVICE COMPONENT WHICH ENSURES THAT THE AXLE WITHIN THE KNEE JOINT REMAINS IN PLACE. THE REVISION WAS SUCCESSFULLY COMPLETED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443020 METS DISTAL FEMUR REPLACEMENT IMPLANT LIMB SPARING SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD. MKFE/RSM A9088

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention