BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX54OD

    MDR report key: 3021099 · Received March 26, 2013

    Report

    Report Number
    1818910-2013-14447
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    February 28, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 LOT CODES 1211225, 1229261, XE2C21005, 2421648, YW3C61000, Y1WDB1000, B2YFN1000, B45HS1000, AND B2RBW1000. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 2457575 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A PREVIOUS 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.

    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

    PATIENT SEEKING LEGAL ACTION. PFS RECEIVED. MEDICAL RECORDS RECEIVED. PFS ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, SWELLING, DISCOMFORT, ELEVATED LEVELS OF COBALT CHROMIUM, AND STEM LOOSENING ON THE RIGHT SIDE. RECORDS ARE AVAILABLE ON THE L DRIVE IF NEEDED FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124450 PINNACLE MTL INS NEUT36IDX54OD METAL LINER KWA DEPUY ORTHOPAEDICS INC US 2421648

    Patients

    Seq Age Sex Outcome Treatment
    1 Other