BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY PINNACLE SECTOR 2 SZ MM 58

    MDR report key: 1977755 · Received January 30, 2011

    Report

    Report Number
    MW5019218
    Event Type
    Malfunction
    Date Received
    January 30, 2011
    Date of Event
    September 8, 2009
    Report Date
    January 30, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS INC.
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RIGHT HIP SURGERY (B)(6) 2009. SIX MONTHS AFTER SURGERY RIGHT GROIN PAIN AS WELL AS RIGHT OUTER HIP PAIN, METAL TASTE IN MOUTH, SWEATING TO COLD SWEATS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY PINNACLE SECTOR 2 SZ MM 58 DEPUY PINNACLE CUP KWA DEPUY ORTHOPAEDICS INC. PINNACLE METAL C6DEV1000
    2 DEPUY ACETABULAR CUP PINNACLE SECTOR 2 SZ MM 58 DEPUY PINNACLE CUP KWA DEPUY ORTHOPAEDICS INC. PINNACLE METAL C6DEV1000
    3 PINNACLE METAL INSERT NEUTRAL 40MM ID X 58MM OD INSERT KWA DEPUY ORTHOPAEDICS INC. PINNACLE METAL 2837
    4 ARTICUL/EZE R M -SPEC FEMORAL HEAD 040MM - 2OFFSET 12/14 TAPER FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC. PINNACLE METAL 2683957
    5 SUMMITT FEMORAL STEM 12/14 TAPERED W/POROCOAT FEMORAL STEM KWA DEPUY ORTHOPAEDICS INC. PINNACLE METAL DX1HT1

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR