BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL FEMUR JTS / PROXIMAL TIBIA MIG

    MDR report key: 4672008 · Received April 7, 2015

    Report

    Report Number
    3004105610-2015-00034
    Event Type
    Injury
    Date Received
    April 7, 2015
    Date of Event
    April 30, 2015
    Report Date
    March 10, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    PMA / PMN Number
    K133152
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORDS WERE REVIEWED WITH NO NON-CONFORMANCES IDENTIFIED. A NEW PROSTHESIS IS BEING DESIGNED FOR THE REVISION. NOTE THAT THE CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT IS SIMILAR TO A PATIENT SPECIFIC DISTAL FEMORAL IMPLANT (K140898).

    Additional Manufacturer Narrative · 1

    DURING THE COMPLAINT INVESTIGATION, STANMORE IMPLANTS LEARNED THAT THE IMPLANT WHICH REQUIRED REVISION WAS (B)(4) AND NOT (B)(4). IN (B)(6) 2014, STANMORE IMPLANTS PROVIDED (B)(4) FOR THIS PATIENT FOR REVISION OF (B)(4), HOWEVER THE REVISION PROCEDURE DID NOT TAKE PLACE. AFTER A SECOND CUSTOM REVISION IMPLANT WAS ORDERED FOR THIS PATIENT IN (B)(6) 2015, THE HOSPITAL REALIZED THAT CUSTOM IMPLANT (B)(4) WAS AVAILABLE FOR USE AND CANCELED THE (B)(6) 2015 ORDER. THUS THE IN SITU IMPLANT (B)(4) WAS REPLACED WITH A DISTAL FEMUR PROXIMAL TIBIA IMPLANT (B)(4) WITH NO COMPLICATIONS REPORTED ON (B)(6) 2015. A REVIEW OF THE DEVICE MANUFACTURING HISTORY FOR (B)(4) CONFIRMS THERE WAS NO EVIDENCE THAT NON-CONFORMING PRODUCT WAS RELEASED. THE REVISION PROCEDURE WAS REQUIRED AS THE DISTAL FEMUR JTS / PROXIMAL TIBIA MIG DEVICE HAD REACHED MAXIMUM EXTENSION. THERE IS NO FAILURE OF THE FIVE YEAR OLD IN-SITU IMPLANT; THE DEVICE FUNCTIONED AS INTENDED. THE (B)(6) PATIENT HAS CONTINUED TO GROW, THUS REQUIRING A NEW DEVICE TO ADDRESS THE LEG LENGTH DISCREPANCY BETWEEN HER IMPLANT LEG AND HER LEFT LEG. THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED. THE COMPLAINT IS BEING TRACKED AND TRENDED.

    Description of Event or Problem · 1

    SUPPLEMENTAL REPORT TO (B)(4). THE PATIENT DID NOT UNDERGO A REVISION PROCEDURE IN (B)(6) 2014 AS PREVIOUSLY REPORTED. STANMORE IMPLANTS SUBSEQUENTLY LEARNED THAT THE CUSTOM IMPLANT PROVIDED BY STANMORE IMPLANTS IN (B)(6) 2014 WAS NOT IMPLANTED. IN (B)(6) 2015, THE PATIENT'S DISTAL FEMUR JTS / PROXIMAL TIBIA MIG IMPLANT WAS REPORTED TO HAVE REACHED MAXIMUM EXTENSION AND REQUIRED REPLACEMENT. THUS THE SURGEON PLACED A CUSTOM REVISION IMPLANT ORDER AT THAT TIME. HOWEVER, THIS CUSTOM IMPLANT ORDER WAS LATER DETERMINED BY THE HOSPITAL TO BE UNNECESSARY, AS THE CUSTOM IMPLANT SUPPLIED IN (B)(6) 2014 WAS AVAILABLE TO BE IMPLANTED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A REVISION IN (B)(6) 2014 DUE TO REACHING THE MAXIMUM EXTENSION ON THEIR CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT AND THEIR CUSTOM PROXIMAL TIBIA REPLACEMENT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228775 DISTAL FEMUR JTS / PROXIMAL TIBIA MIG PROSTHESIS, KNEE, FEMOROTIBIAL, CONS KRO STANMORE IMPLANTS WORLDWIDE LTD. PIN 14935 / PIN 15275

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention