BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD INSERT

    MDR report key: 2638451 · Received July 3, 2012

    Report

    Report Number
    1818910-2012-15683
    Event Type
    Injury
    Date Received
    July 3, 2012
    Date of Event
    November 30, 2011
    Report Date
    January 2, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K001523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES ON PRODUCT LOT 1046008, 1077816 1082947 IDENTIFIED NO PREVIOUS COMPLAINTS. A SEARCH OF THE COMPLAINTS DATABASES ON PRODUCT LOT 1069478 IDENTIFIED ONE PREVIOUS COMPLAINT THAT WAS RAISED REGARDING NECROSIS AND METALLOSIS. IT WAS CLOSED WITH AN UNDETERMINED CONCLUSION. THE PATIENT UNDERWENT A RIGHT TOTAL HIP REPLACEMENT ON (B)(6) 2003. IT WAS NOTED DURING THE PROCEDURE, THE NATURAL FEMORAL HEAD WAS IN "GROSS ANTEVERSION AND THE ACETABULUM WAS DYSPLASTIC MAKING THIS A COMPLEX PRIMARY. THIS MAY EXPLAIN THE SUPERIOR POSITION OF THE SHELL AND HEAD CENTRE WHEN COMPARED TO THE CONTRALATERAL. THERE IS INSUFFICIENT INFORMATION AVAILABLE TO REACH A ROOT CAUSE AS THE REASON FOR REVISION IS UNCLEAR, NO PRODUCT HAS BEEN RETURNED FOR REVIEW, NO HISTOLOGY HAS BEEN PROVIDED AND NO REVISION NOTES ARE PRESENT. THIS WAS A COMPLEX PRIMARY AND THE IMPLANT POSITION DIFFERS TO THE LANDMARKS ON THE CONTRA-LATERAL IN TERMS OF HEAD CENTRE, CUP POSITION, OFFSET AND POSSIBLY LEG LENGTH. THE PATIENT WAS ADVISED NOT TO LIFT ITEMS FROM LORRIES, OR, FROM THE FLOOR. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES ON PRODUCT LOT 1046008, 1077816 1082947 IDENTIFIED NO PREVIOUS COMPLAINTS. A SEARCH OF THE COMPLAINTS DATABASES ON PRODUCT LOT 1069478 IDENTIFIED ONE PREVIOUS COMPLAINT THAT WAS RAISED REGARDING NECROSIS AND METALLOSIS. IT WAS CLOSED WITH AN UNDETERMINED CONCLUSION. THE PATIENT UNDERWENT A RIGHT TOTAL HIP REPLACEMENT ON (B)(6) 2003. IT WAS NOTED DURING THE PROCEDURE, THE NATURAL FEMORAL HEAD WAS IN GROSS ANTEVERSION AND THE ACETABULUM WAS DYSPLASTIC MAKING THIS A COMPLEX PRIMARY. THIS MAY EXPLAIN THE SUPERIOR POSITION OF THE SHELL AND HEAD CENTRE WHEN COMPARED TO THE CONTRALATERAL. THERE IS INSUFFICIENT INFORMATION AVAILABLE TO REACH A ROOT CAUSE AS THE REASON FOR REVISION IS UNCLEAR, NO PRODUCT HAS BEEN RETURNED FOR REVIEW, NO HISTOLOGY HAS BEEN PROVIDED AND NO REVISION NOTES ARE PRESENT. THIS WAS A COMPLEX PRIMARY AND THE IMPLANT POSITION DIFFERS TO THE LANDMARKS ON THE CONTRA-LATERAL IN TERMS OF HEAD CENTRE, CUP POSITION, OFFSET AND POSSIBLY LEG LENGTH. THE PATIENT WAS ADVISED NOT TO LIFT ITEMS FROM LORRIES, OR, FROM THE FLOOR. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE REQUIRED PRODUCT/LOT CODE COMBINATIONS WERE NOT PROVIDED. THE INVESTIGATION CAN DRAW NO CONCLUSION REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    RIGHT HIP REPLACMENT IN (B)(6) 2003, WORSENING PAIN IN 2011, BLOOD SAMPLES TAKEN SHOWING ELEVATED METAL IONS. MRI SCAN CARRIED OUT ON (B)(6) 2011 SHOWING BUILD UP OF FLUID AS A RESULT OF METAL PARTICLES.

    Description of Event or Problem · 1

    FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD INSERT ACETABULAR INSERT KWA DEPUY INTERNATIONAL 1069478

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention