BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE 100 ACETABULAR CUP SZ 56 MM

    MDR report key: 3254864 · Received July 24, 2013

    Report

    Report Number
    MW5031113
    Event Type
    Injury
    Date Received
    July 24, 2013
    Date of Event
    September 18, 2009
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2009, I UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY PROCEDURE. I RECEIVED A DEPUY PINNACLE CUP, NO-HLE 56 MM, A 40 MM METAL LINER, A SUMMIT SZ 6, STANDARD OFFSET STEM AND A 40 MM METAL LINER, A SUMMIT SZ 6, STANDARD OFFSET STEM AND A 40 MM +8.5 DEPUY ASPHERE M-SPEC METAL-METAL FEMORAL HEAD. SOON AFTER SURGERY, I BEGAN EXPERIENCING PAIN AND DIFFICULTY WITH MY IMPLANT. SINCE THE IMPLANTATION OF THE PINNACLE DEVICE, I EXPERIENCE SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN MY LEFT THIGH AND LEFT HIP AREA. I ALSO FEEL EXTREME DISCOMFORT WHEN SITTING, WALKING, OR STANDING FOR PERIODS OF TIME. DIAGNOSIS OR REASON FOR USE: LEFT FEMORAL NECK FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344471 DEPUY PINNACLE 100 ACETABULAR CUP SZ 56 MM METAL ON METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS, INC. 1570-02-120 D3AHL1000
    344472 40MM METAL INSERT METAL INSERT KWA DEPUY
    344473 SUMMIT SZ 6 STANDARD OFFSET STEM HIP STEM LWJ DEPUY
    344474 40MM +8.5 DEPUY ASPHERE M-SPEC METAL-METAL FEMORAL HEAD FEMORAL HEAD KWY DEPUY

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R| S