BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC*SIGMA C/S NPOR FEM LT SZ 4

    MDR report key: 2270339 · Received September 30, 2011

    Report

    Report Number
    1818910-2011-19432
    Event Type
    Malfunction
    Date Received
    September 30, 2011
    Report Date
    September 20, 2011
    Manufacturer
    DEPUY IRELAND
    Product Code
    JWH
    PMA / PMN Number
    K950010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED EVENT. PERIPHERY SYSTEMS REVIEWED AND FOUND TO MEET SPECIFICATIONS/ BE ACCEPTABLE (ADDITIONAL DATA REVIEW - ADD AS APPLICABLE). CORRECTIVE ACTION FOR SIMILAR COMPLAINTS IS BEING PERFORMED AND RECORDED (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD 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

    CUSTOMER REVEALED THAT 1 BOX OF ITEM 960044 (LOT NO 3269882) CONTAINED ANOTHER FEMORAL COMPONENT (INSIDE OF BOX), CORRESPONDING TO ITEM (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC*SIGMA C/S NPOR FEM LT SZ 4 FEMORAL COMPONENT JWH DEPUY IRELAND 3269882

    Patients

    Seq Age Sex Outcome Treatment
    1