BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PINNACLE CUP

    MDR report key: 3950123 · Received July 22, 2014

    Report

    Report Number
    1818910-2014-23973
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    October 4, 2013
    Report Date
    June 23, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PROVIDED PRODUCT/LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. THE SEARCH WAS NOT POSSIBLE FOR THE REMAINING PRODUCTS AS THE PRODUCT/LOT CODE COMBINATIONS WERE NOT PROVIDED. NO FURTHER EVENT INFORMATION OR INVESTIGATIONAL INPUTS WERE PROVIDED TO CUSTOMER QUALITY. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM (B)(6) RE: ASR. POSSIBLE REVISION OF PINNACLE PRODUCTS, FOLLOWING ON FROM AN ASR REVISION. ASR IMPLANTED (B)(6) 2005. ASR REVISED (?) (B)(6) 2013. ADDITIONAL 'SURGERY' MENTIONED ON (B)(6) 2013. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428658 UNKNOWN PINNACLE CUP HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS, INC.1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention