BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MULTIHOLE II CUP 50MM

    MDR report key: 3943338 · Received July 18, 2014

    Report

    Report Number
    1818910-2014-23716
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    KWA
    PMA / PMN Number
    PK073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICES FINDS EVIDENCE TO SUPPORT DISASSOCIATION OF THE LINER AND CUP WHILE IMPLANTED. THE RETURNED FEMORAL HEAD EXHIBITS SIGNS OF COMING INTO DIRECT CONTACT WITH THE ACETABULAR CUP, FURTHER SUPPORTING THE DISASSOCIATION. IN THIS CASE 4 OF THE ARD'S OF THE POLYETHYLENE LINER HAVE FRACTURED AS WELL AS THE LOADED EDGE. IT IS EVIDENT THAT THE EDGE OF THE LINER WAS LOADED BY THE FEMORAL HEAD AND PATIENT BODY WEIGHT WHILE IMPLANTED. THERE ARE MACHINING LINES YET VISIBLE WITHIN THE INNER RADIUS OF THE LINER WHICH WOULD NOT BE AS OBVIOUSLY PRESENT HAD THE FEMORAL HEAD BEEN MORE CENTRALLY LOADED. AS NO PATIENT X-RAYS WERE PROVIDED, IMPLANT POSITIONING CANNOT BE COMMENTED UPON. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PROVIDED PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISASSOCIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423167 PINNACLE MULTIHOLE II CUP 50MM HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS, INC.1818910 D1WDV1000

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention