BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX35MM

    MDR report key: 3005776 · Received March 15, 2013

    Report

    Report Number
    1818910-2013-04355
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    November 24, 2010
    Report Date
    November 14, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NDJ
    PMA / PMN Number
    K983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE LOT CODES 3107633, 2982946, CP8JT1, AND 423489. A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS ONE ADDITIONAL REPORTED INCIDENT AGAINST LOT CODE 430081 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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

    LITIGATION ALLEGES SEVERE PAIN, DISCOMFORT, INFLAMMATION, AND ELEVATED LEVELS OF COBALT CHROMIUM METAL IONS AND PARTICLES IN THE BLOOD AND TISSUE SURROUNDING THE IMPLANT. LITIGATION ALSO ALLEGES THAT THE PATIENT HAS A PERIODIC CLICKING IN HER LEFT HIP. UPDATE: (B)(4) 2012 MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS INDICATE THAT THE PATIENT WAS REVISED BECAUSE OF ACETABULAR LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109669 PINN CAN BONE SCREW 6.5MMX35MM BONE SCREW NDJ DEPUY ORTHOPAEDICS INC US 430081

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention