BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE HEAD

    MDR report key: 3063183 · Received April 17, 2013

    Report

    Report Number
    1818910-2013-15474
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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.

    Additional Manufacturer Narrative · 1

    FOLLOWING INVESTIGATION BY BIOENGINEERING, NOTIFICATION WAS RECEIVED THAT: ROOT CAUSE: UNDETERMINED, FROM THE LIMITED INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DETERMINE WHY THIS TOTAL HIP REPLACEMENT RECURRENTLY DISLOCATED REQUIRING REVISION. IT IS LIKELY IT WAS AN UNKNOWN COMBINATION OF FACTORS SUCH AS IMPLANT FACTORS, PATIENT FACTORS, SURGICAL TECHNIQUE AND SURGICAL PROCEDURE. GIVEN THE REVISION PROCEDURE CHANGED THE ORIENTATION OF THE LINER IT WOULD APPEAR THAT IMPLANT POSITION MAY HAVE CONTRIBUTED MAKING IT UNLIKELY IT WAS A MANUFACTURING FAULT WITH THE DEVICE. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION. IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED, THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER. 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

    PATIENT HAS HAD A NUMBER OF SUBSEQUENT DISLOCATIONS. A DECISION WAS MADE TO OPEN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165958 ELITE HEAD HEAD BALL KWY DEPUY ORTHOPAEDICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention