BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX50OD

    MDR report key: 2944025 · Received February 5, 2013

    Report

    Report Number
    1818910-2013-11918
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    November 5, 2012
    Report Date
    January 25, 2013
    Manufacturer
    DEPUY INTL., LTD. ¿ REG. # 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK083642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR 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

    (B)(4) REPORT ((B)(4)) SUBMITTED BY AN ATTORNEY STATES THAT A PATIENT HAD PAIN, POPPING/CLICKING/CLUNK WHILE WALKING. IT WAS NOTED THERE WAS SOME "UNCOVERAGE OF THE SUPEROLATERAL ACETABULUM." BY 2012, PATIENT HAD SEVERE CONSTANT PAIN RADIATING INTO THE THIGH, AND METAL LEVELS WERE ELEVATED. PATIENT WAS REVISED. IT WAS NOTED THAT THE JOINT CAPSULE WAS FULL OF DARK GREY FLUID AND THERE WAS A LARGE AMOUNT OF METALLOSIS IN THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47445 PINNACLE MTL INS NEUT36IDX50OD ACETABULAR LINER KWA DEPUY INTL., LTD. ¿ REG. # 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention