BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 54MM

    MDR report key: 3143256 · Received June 3, 2013

    Report

    Report Number
    1818910-2013-18076
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    June 8, 2011
    Report Date
    May 14, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES E4XHN1, 3146999, AND BP2E41. A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE BN9EY1 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT 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

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORT OF 1818910-2013-18513. THIS REPORT, 1818910-2013-18076, WILL BE KEPT FOR INVESTIGATION PURPOSES. A SEPARATE FOLLOW-UP REPORT WILL BE SUBMITTED TO REJECT 1818910-2013-18513.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT. PATIENT REVISED FOR INFECTION. DOI (B)(6) 2011, DOR (B)(6) 2011 (RIGHT HIP).

    Description of Event or Problem · 1

    PPF ALLEGES FRACTURE OF THE BONE, DISLOCATION WITH CLOSED REDUCTION, INFECTION AND ELEVATED METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244974 PINNACLE SECTOR II CUP 54MM ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US BN9EY1000

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention