BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY PINNACLE METAL LINER

    MDR report key: 2942403 · Received February 4, 2013

    Report

    Report Number
    1818910-2013-11848
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 7, 2013
    Report Date
    March 13, 2013
    Manufacturer
    8010379 DEPUY INTL., LTD
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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

    PLEASE DISREGARD THIS MEDWATCH AS IT WAS CREATED IN ERROR.

    Additional Manufacturer Narrative · 1

    ONLY THE HEAD WAS REPLACED, THE METAL LINER WAS LEFT IN THE PATIENT. THIS IS A DUPLICATE OF 1818910-2013-01423.

    Additional Manufacturer Narrative · 1

    CORRECTED: THIS REPORT IS A DUPLICATE OF 1818910-2015-20333 . THIS REPORT, 1818910-2013-11848, WILL BE REJECTED. REPORT 1818910-2015-20333 WILL BE KEPT FOR INVESTIGATIONAL PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE METAL HEAD PROVIDED PART AND LOT CODE COMBINATION. A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE METAL LINER AS THE PRODUCT AND LOT COMBINATION WAS NOT PROVIDED. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM HARM AND DAMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46515 UNKNOWN DEPUY PINNACLE METAL LINER METAL LINER JDI 8010379 DEPUY INTL., LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other