BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE ACETABULAR CUP SYSTEM

    MDR report key: 3020692 · Received March 18, 2013

    Report

    Report Number
    MW5029440
    Event Type
    Injury
    Date Received
    March 18, 2013
    Date of Event
    February 18, 2008
    Report Date
    March 18, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    CLOSED REDUCTION OF DISLOCATED LEFT HIP. THERAPY FROM (B)(6) 2008 - (B)(6) 2008. PAIN PRESENT AND LIMP STILL EVIDENT. NO MEDICATIONS. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112325 PINNACLE ACETABULAR CUP SYSTEM NONE KWA DEPUY ORTHOPAEDICS
    112326 PINNACLE HIP IMPLANT WITH MOM LINER NONE KWA DEPUY ORTHOPAEDICS
    112327 ACETABULAR CUP: PINNACLE SECTOR II NONE JDI DEPUY ORTHOPAEDICS LOT # CB2GG1000
    112328 CANCELLOUS BONE SCREW: PINNACLE 6.5 MM X 15 MM NONE HWC DEPUY ORTHOPAEDICS B4KAN4000
    112329 CANCELLOUS BONE SCREW: PINNACLE 6.5 MM X 15 MM NONE HWC DEPUY ORTHOPAEDICS BTICI4000
    112330 8" BOWED IMPLANT: 8/16.5 SOLUTION SYSTEM, SIZE LARGE NONE JDI DEPUY ORTHOPAEDICS A69HF1000
    112331 ARTICUL / EZE: METAL ON METAL FEMORAL HEAD NONE JDI DEPUY ORTHOPAEDICS 2507456
    112332 PINNACLE METAL INSERT NONE KWA DEPUY ORTHOPAEDICS 2451735

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R| S