BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMORAL REPLACEMENT IMPLANT

    MDR report key: 5842941 · Received August 3, 2016

    Report

    Report Number
    3004105610-2016-00063
    Event Type
    Malfunction
    Date Received
    August 3, 2016
    Date of Event
    July 4, 2016
    Report Date
    July 4, 2016
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K140898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE MANUFACTURING HISTORY RECORDS CONFIRMS THAT NO NON-CONFORMING PRODUCT WAS RELEASED. THE INVESTIGATION IS ONGOING AND THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS IN-SITU OVER 20 YEARS AND THE REBUSHING PROCEDURE HAS NOT BEEN SCHEDULED. BASED ON THE INFORMATION PROVIDED A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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 REBUSHING IS AN ANTICIPATED EVENT OVER THE LIFETIME OF AN ORTHOPAEDIC IMPLANT, PERFORMED AT THE DISCRETION OF THE SURGEON. IT CONSISTS OF THE REPLACEMENT OF POLY COMPONENTS WHICH ARE SUSCEPTIBLE TO WEAR SUCH AS BEARINGS AND BUSHINGS, IN ADDITION TO THE AXLE AND RELATED RETAINING MECHANISMS. A REVIEW OF THE DEVICE HISTORY MANUFACTURING RECORDS CONFIRMS THAT NO NON-CONFORMING PRODUCT WAS RELEASED. THIS COMPLAINT IS BEING CLOSED AND IS BEING TRACKED AND TRENDED. CORRECTED DATA BRAND NAME IS CORRECTED FROM "DISTAL FEMUR" TO "CUSTOM DISTAL FEMORAL REPLACEMENT IMPLANT". EXPIRY DATE IS CORRECTED FROM 09/30/1996 TO 09/25/1996.

    Description of Event or Problem · 1

    (B)(4). THE SURGEON PLACED AN ORDER FOR A REBUSHING (REPLACEMENT OF THE PLASTIC COMPONENTS) OF THE PATIENT'S CUSTOM DISTAL FEMUR DEVICE WHICH WAS IMPLANTED 20 YEARS AGO. THE CASE HAS NOT YET BEEN SCHEDULED/CONFIRMED.

    Description of Event or Problem · 1

    THE SURGEON PLACED AN ORDER FOR A REBUSHING (REPLACEMENT OF THE PLASTIC COMPONENTS) OF THE PATIENT'S CUSTOM DISTAL FEMUR DEVICE WHICH WAS IMPLANTED 20 YEARS AGO. THE CASE HAS NOT YET BEEN SCHEDULED/CONFIRMED. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2016-00063 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495761 CUSTOM DISTAL FEMORAL REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD PIN 4134 PIN 4134

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other