BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METS DISTAL FEMUR

    MDR report key: 4955620 · Received July 31, 2015

    Report

    Report Number
    3004105610-2015-00069
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Report Date
    July 6, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K121029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS THAT THE DEVICE WAS MANUFACTURED WITHIN SPECIFICATION WITH NO ABNORMALITIES OR DEVIATIONS. THE STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR DEVICE IS A MODULAR SYSTEM WITH A VARIETY OF COMPONENTS THAT CAN BE FITTED TOGETHER. A REVIEW OF THE DEVICE LABELLING CONFIRMED THAT THE METS DISTAL FEMUR OPERATION TECHNIQUE OUTLINES THE COMPONENTS OF THE DEVICE IN SECTION 1 DEVICE INFORMATION. THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED IN THE PAST 24 MONTHS. HOWEVER, ADDITIONAL INFORMATION HAS BEEN REQUESTED IN ORDER TO CLARIFY THE SURGEON'S COMMENTS REGARDING MODULARITY AND THE PATELLA BUTTON. A SUPPLEMENTAL REPORT WILL BE PROVIDED. IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE SURGEON SUCCESSFULLY COMPLETED THE REVISION PROCEDURE. IT WAS REPORTED THAT THE DOCTOR WAS PLEASED WITH THE FINAL OUTCOME AND APPRECIATES THE MANY UNIQUE AND POSITIVE DESIGN FEATURES THAT STANMORE OFFERS. THE SURGEON'S COMMENTS STATING THAT "WOULD BE NICE FOR A BIT MORE MODULARITY FOR REVISION SITUATIONS WITH THE METS SYSTEM" DOES NOT FALL UNDER THE DEFINITION OF A COMPLAINT AND HENCE WILL NOT BE INVESTIGATED. THE SURGEON STATED THAT "NORMAL PATELLA BUTTONS DON'T FIT THE TROCHLEAR GROOVE WELL", PATELLA BUTTONS ARE NOT SUPPLIED BY SIW AND HENCE THIS CANNOT BE CONSIDERED A COMPLAINT. THE SURGEON HAS NOT ALLEGED A DEVICE FAILURE. THE EVENT IS RELATED TO A SURGEON PREFERENCE RATHER THAN A COMPLAINT AS DEFINED IN ISO13485:2016 OR 21CFR820. THIS COMPLAINT IS BEING CLOSED AND IS BEING TRACKED AND TRENDED. LIMB SPARING SYSTEM CORRECTED TO LIMB SALVAGE SYSTEM. 510K CORRECTED FROM K120992 TO K121029.

    Description of Event or Problem · 1

    DURING A METS DISTAL FEMUR PROCEDURE THE SURGEON REPORTED THAT IT "WOULD BE NICE FOR A BIT MORE MODULARITY FOR REVISION SITUATIONS" WITH THE METS SYSTEM AND THAT "NORMAL PATELLA BUTTONS DON'T FIT THE TROCHLEAR GROOVE WELL. A 32 MM BUTTON SEEMED TOO LARGE FOR THE GROOVE IN THE METS DISTAL FEMUR". THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE SURGEON WAS HAPPY WITH THE OUTCOME.

    Description of Event or Problem · 1

    DURING A METS DISTAL FEMUR PROCEDURE THE SURGEON REPORTED THAT IT "WOULD BE NICE FOR A BIT MORE MODULARITY FOR REVISION SITUATIONS" WITH THE METS SYSTEM AND THAT "NORMAL PATELLA BUTTONS DON'T FIT THE TROCHLEAR GROOVE WELL. A 32MM BUTTON SEEMED TOO LARGE FOR THE GROOVE IN THE METS DISTAL FEMUR". THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE SURGEON WAS HAPPY WITH THE OUTCOME. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2015-00069 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501735 METS DISTAL FEMUR LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD A9452

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other