BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT44IDX64OD

    MDR report key: 3231482 · Received July 17, 2013

    Report

    Report Number
    1818910-2013-21442
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    March 21, 2014
    Report Date
    July 1, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    K062426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    ADDITIONAL NARRATIVE: THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE REPORTED LOT CODE 2585773 OR 2342382. 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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES PAIN, DISCOMFORT, INFLAMMATION, POPPING AND SNAPPING AND ELEVATED METAL ION LEVELS.

    Description of Event or Problem · 1

    PPF ALLEGES PSEUDOTUMOR, LOOSENING OF CUP, METAL WEAR METALLOSIS AND ELEVATED METAL IONS. ADDED PATIENT'S AGE, STATE, DATE OF REVISION, SURGEON, LAW FIRM AND PRODUCT DETAILS. ADDED CUP AND SCREWS DUE TO ITS REVISION OF ALLEGED LOOSENING OF CUP. STEM IS A NON DEPUY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330606 PINNACLE MTL INS NEUT44IDX64OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS KWA DEPUY ORTHOPAEDICS, INC. 1818910 2585773

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other