BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 100 ACET CUP 48MM

    MDR report key: 3243155 · Received July 23, 2013

    Report

    Report Number
    1818910-2013-21924
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 25, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC
    Product Code
    KWA
    PMA / PMN Number
    PK073504
    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

    VISUAL EXAMINATION OF THE RETURNED DEVICES SUGGESTS THE LINER DISASSOCIATED AND ALLOWED THE FEMORAL HEAD TO CONTACT THE ACETABULAR CUP. IN THIS CASE A PORTION OF THE RIM OF THE POLYETHYLENE LINER HAS FRACTURED. 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. THE EDGE LOADING OF THE LINER HAS PLACED PRESSURES ON THE MATERIAL NEAR THE RIM THAT WERE NOT INTENDED LEADING TO A FRACTURE OF THE MATERIAL AND SUBSEQUENT DISASSOCIATION OF THE LINER FROM THE CUP. IT IS SUSPECTED THAT THE ACETABULAR CUP WAS POSITIONED MORE VERTICALLY THAN RECOMMENDED BY SURGICAL TECHNIQUE CONTRIBUTING TO THE EDGE LOADING. PATIENT X-RAYS WERE REQUESTED BUT NOT PROVIDED. PLACEMENT CANNOT BE COMMENTED UPON. IT SHOULD BE NOTED, THE ACETABULAR COMPONENT WAS NOT RETURNED AS IT REMAINS IN SITU AND MATCHING DAMAGE CANNOT BE CONFIRMED. A SEARCH OF THE COMPLAINTS DATABASES AGAINST THE PROVIDED PRODUCT AND LOT CODE COMBINATIONS FOUND NO OTHER REPORTS. THE INVESTIGATION CAN DRAW NO CONCLUSIONS 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 INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    REVISED FOR DISASSOCIATION OF LINER/CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342614 PINNACLE 100 ACET CUP 48MM ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention