BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE 100 ACETABULAR CUP SYSTEM

    MDR report key: 3010775 · Received March 13, 2013

    Report

    Report Number
    MW5029392
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A RIGHT TOTAL HIP REPLACEMENT ON (B)(6) 2007. I RECEIVED THE DEPUY TOTAL HIP SYSTEM PINNACLE 100 ACETABULAR CUP SZ MM58. PRIOR TO SURGERY, I HAD DISCOMFORT THAT COULD BE DULL AND THEN SHARP. IT RADIATED FROM MY GROIN TO MY LATERAL HIP. AFTER SURGERY, THE PAIN WENT AWAY BUT THEN IN (B)(6) 2009, I HAD START UP PAIN WHEN I WENT FROM A SIT TO A STAND AND BEGAN TO WALK. THE PAIN WAS LOCATED IN THE GROIN AND RADIATED TO MY THIGH. LABORATORY LEVELS SHOWED ELEVATED CHROMIUM LEVELS. AP AND LATERAL X-RAYS IN (B)(6) 2009 SHOWED FURTHER SUBSIDENCE OF THE IMPLANT AND SHOCKINGLY A FRACTURE OF THE FEMORAL STEM AT THE JUNCTION OF THE FORK WITH THE SOLID PART OF THE STEM INTO LATERALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106502 DEPUY PINNACLE 100 ACETABULAR CUP SYSTEM METAL-ON-METAL HIP IMPLANT KWA DEPUY ORTHOPAEDICS, INC 1217-01-058 BX4CL1000
    106503 PINNACLE NEURAL 40MMX66MMOD METAL INSERT LPH DEPUY ORTHOPAEDICS, INC 1218-87-458 2394920
    106504 S-ROM TOTAL HIP SYSTEM PROXIMAL SLEEVE JDI DEPUY ORTHOPAEDICS, INC 55-0535 2420352
    106505 DEPUY APEX HOLE ELIMINATOR JDI DEPUY ORTHOPAEDICS, INC 1246-03-000 B11A91000
    106506 S-ROM TOTAL HIP SYSTEM 20X16X165 56 STD NECK +12 LATERAL FEMORAL STEM STANDARD JDI DEPUY ORTHOPAEDICS, INC 56-3620 2334227
    106507 S-ROM 40MM +12 OFFSET 11/13 TAPER FEMORAL HEAD JDI DEPUY ORTHOPAEDICS, INC 1365-47-500 2362966

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S PHYSICAL THERAPY ((B)(6) 2010)