BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 54MM

    MDR report key: 3430864 · Received October 27, 2013

    Report

    Report Number
    1818910-2013-31613
    Event Type
    Injury
    Date Received
    October 27, 2013
    Date of Event
    October 10, 2013
    Report Date
    October 10, 2013
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    LPH
    PMA / PMN Number
    PK000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) REPORTS THAT THE PATIENT WAS REVISED TO ADDRESS ONGOING INFECTION. DOI (B)(6) 2013 - DOR (B)(6) 2013 (LEFT HIP). NOTE: PATIENT WAS PREVIOUSLY REVISED DUE TO INFECTION ON (B)(6) 2013, WITH THE HEAD, LINER, AND A SCREW BEING REMOVED. ON (B)(6) 2013, THE HEAD (136552000; LOT 6041861), LINER (122136054; LOT 420979), AND A SCREW 121745500; LOT D11070723) WERE ALSO EXCHANGED; HOWEVER, THE PATIENT WAS ALREADY BEING TREATED FOR INFECTION WHEN THESE PARTS WERE IMPLANTED ON (B)(6) 2013. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS ONGOING INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550706 PINNACLE SECTOR II CUP 54MM ACETABULAR LINER LPH 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC 413428

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention