BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMORAL REPLACEMENT IMPLANT

    MDR report key: 4373373 · Received December 23, 2014

    Report

    Report Number
    3004105610-2014-00131
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K140898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE OF THE ASEPTIC LOOSENING HAS NOT BEEN IDENTIFIED, HOWEVER ASEPTIC LOOSENING IS A WELL-KNOWN MODE OF FAILURE FOR ORTHOPAEDIC IMPLANTS, WHICH MAY OCCUR AS AN EARLY OR A LATE COMPLICATION. THE REPORTED STEM LOOSENING COULD BE AS A RESULT OF PATIENT FACTORS SUCH AS TRAUMA, OBESITY, ACTIVITY LEVELS OR DISEASE PROGRESSION AND/OR SURGICAL FACTORS OR PREFERENCES AND NOT NECESSARILY RELATED TO THE DEVICE ITSELF. EVENT DATE CORRECTED FROM (B)(6) 2012 TO (B)(6) 2013 COMMON DEVICE NAME/PRODUCT CODE CORRECTED FROM "CUSTOM DISTAL FEMUR" TO "LIMB SALVAGE SYSTEM/KRO."

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. RADIOGRAPHICAL REVIEW INDICATED THAT THE FEMORAL STEM HAS PERFORATED THE FEMORAL BONE. POST OP X-RAYS WOULD CONFIRM WHETHER THIS WAS DUE TO SURGICAL TECHNIQUE OR LOOSENING AND MIGRATION OVER TIME. REQUESTS ARE BEING MADE FOR ADDITIONAL INFO AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFO IS RECEIVED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR DISTAL FEMUR IMPLANT (K121029).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PT UNDERWENT A DISTAL FEMORAL REPLACEMENT ON (B)(6) 2002 AND DUE TO A MIGRATION REQUIRES A NEW IMPLANT FOR REVISION SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A DISTAL FEMORAL REPLACEMENT ON (B)(6) 2002 AND DUE TO A MIGRATION REQUIRES A NEW IMPLANT FOR REVISION SURGERY. FINAL SUPPLEMENTAL REPORT FOR 3004105610-2014-00131 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847142 CUSTOM DISTAL FEMORAL REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME9154

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other| R