BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX58OD

    MDR report key: 3041522 · Received April 8, 2013

    Report

    Report Number
    1818910-2013-15076
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 14, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    (B)(4). UPDATE: 8/16/2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. RECORDS INDICATE THAT THE PATIENT WAS REVISED ON THE LEFT HIP BECAUSE OF PAIN, ELEVATED ION LEVELS, AND CORROSION. THERE WAS A CRACK AT THE PRIMARY SURGERY WHICH WAS LEFT ALONE AND DID NOT FACTOR INTO THE REASONS FOR REVISION. THE RIGHT HIP HAS NOT BEEN REVISED BUT THE PATIENT ALSO RECEIVED A SMALL CRACK AT THE PRIMARY BUT DID NOT CAUSE A SERIOUS INJURY. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.BILATERAL- DOI: (B)(6) 2004- (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODE UX9M21003. A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT CODES 1091329, 1122819, 1125687 AND 1122211 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. 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 DISCOMFORT, PAIN, A LIMP, AND ELEVATED LEVELS OF COBALT CHROMIUM. IT IS ALSO ALLEGED THAT THE PATIENT SUFFERS FROM LOOSENING OF THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144026 PINNACLE MTL INS NEUT36IDX58OD METAL LINER KWA DEPUY ORTHOPAEDICS INC US 1091329

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention