BEUDAMED
    FDA Adverse Event Summary report: N

    DEPUY PINNACLE ACETABULAR CUP 54MM

    MDR report key: 3255567 · Received July 24, 2013

    Report

    Report Number
    MW5031148
    Date Received
    July 24, 2013
    Date of Event
    April 6, 2010
    Report Date
    June 18, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, I UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY. I REC'D A DEPUY HIP SYSTEM CONSISTING OF A DEPUY PINNACLE ACETABULAR CUP 54MM, WITH A 36MM X 54MM METAL LINER, A DEPUY TI LOCK 111 MM FEMORAL STEM, AND A DEPUY FEMORAL HEAD 36MM + 1.5. SOON AFTER THIS SURGERY, I BEGAN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN MY RIGHT THIGH AND HIP. I ALSO FEEL EXTREME DISCOMFORT WHILE WALKING. I HEAR GRINDING AND POPPING NOISES IN MY HIP. I ALSO HAVE DIFFICULTY SLEEPING BECAUSE OF ALL OF THE PAIN. MY HIP OFTEN SHIFTS, AND POPS OUT OF SOCKET. REASON FOR USE: POST-TRAUMATIC OSTEOARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346352 DEPUY PINNACLE ACETABULAR CUP 54MM METAL-ON-METAL HIP IMPLANT LPH DEPUY ORTHOPAEDICS, INC. 1217-30-054 D5DA41000
    346353 DEPUY TI-LOCK 111MM FEMORAL STEM METAL-ON-METAL HIP IMPLANT LPH DEPUY ORTHOPAEDICS, INC.
    346354 DEPUY FEMORAL HEAD 36MM + 1.5 METAL-ON-METAL HIP IMPLANT LPH DEPUY ORTHOPAEDICS, INC.
    346524 36MM X 54MM METAL LINER METAL-ON-METAL HIP IMPLANT LPH DEPUY ORTHOPAEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R| S