BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX54OD

    MDR report key: 4323427 · Received December 11, 2014

    Report

    Report Number
    1818910-2014-34075
    Event Type
    Injury
    Date Received
    December 11, 2014
    Date of Event
    November 14, 2014
    Report Date
    November 17, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    ATTORNEY

    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 REPORTED PART AND LOT CODE COMBINATIONS. 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

    THIS IS A DUPLICATE OF 181910-2014-35306. THIS REPORT 181910-2014-34075 WILL BE KEPT FOR INVESTIGATION PURPOSES. A SEPARATE FOLLOW-UP[ REPORT WILL BE SUBMITTED TO REJECT 181910-2014-35306. 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). 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

    LEGAL CLAIM RECEIVED. PATIENT ALLEGES HE SUFFERS FROM POPPING, PAIN, DISCOMFORT, MOBILITY ISSUES, AND ELEVATED CHROMIUM AND COBALT LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805580 PINNACLE MTL INS NEUT36IDX54OD HIP ACETABULAR INSERT/LINER KWA DEPUY INTERNATIONAL LTD 8010379 2721744

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention