BEUDAMED
    FDA Adverse Event Summary report: N

    SMITH AND NEPHEW BHR ACETABULAR CUP

    MDR report key: 3001676 · Received March 8, 2013

    Report

    Report Number
    MW5029317
    Date Received
    March 8, 2013
    Date of Event
    December 11, 2006
    Report Date
    February 5, 2013
    Manufacturer
    SMITH AND NEPHEW
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2006, I HAD A TOTAL HIP ARTHROPLASTY WITH A SMITH AND NEPHEW, METAL ON METAL HIP. AFTER SURGERY, THINGS WERE SATISFACTORY. X-RAYS SHOWED HIP WAS IN PLACE, AND THERE WAS ADEQUATE RANGE OF MOTION. BY 2008, I WAS EXPERIENCING PAIN, 'CLUNKING', AND SOMETIMES I, 'SQUEAKED'. NEW X-RAYS SHOWED NO ABNORMALITIES. AFTER A FEW MORE VISITS, I WAS SENT TO PHYSICAL THERAPY. THERE WERE NO POSITIVE RESULTS. DOCTORS NOT THOUGHT IT MIGHT BE MY BACK, DID AN MRI, AND SENT ME TO PAIN MANAGEMENT. AFTER 3 EPIDURALS WITH STEROIDS AND A LUMBAR STEROID INJECTION, NO RESULTS. JUST PAIN. THE LIMPING GOT WORSE AND PAIN CONTINUED. I WAS GIVEN PAIN MEDS, LYRICA, MUSCLE RELAXANTS, ETC. STILL PAIN AND LIMPING. BY (B)(6) 2011, THE PAIN WAS SO BAD, I COULD HARDLY FUNCTION. IN (B)(6) 2012, I MET WITH DR (B)(6). THE NEW X-RAYS SHOWED SHEARING AROUND JOINT. DOCTOR SUSPECTED METALLOSIS. HE ORDERED AN ASPIRATION OF THE JOINT AND HE DESCRIBED THE JUNK THAT CAME OUT WAS THE COLOR OF COFFEE. IN (B)(6) 2012, I HAD A REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99868 SMITH AND NEPHEW BHR ACETABULAR CUP ACETABULAR CUP KWA SMITH AND NEPHEW 74120152 61013
    99869 SMITH AND NEPHEW MODULAR HEAD SLEEVE HEAD SLEEVE JDI SMITH AND NEPHEW 74222300 9767
    99903 SMITH AND NEPHEW ANTHOLOGY FEMORAL COMPONENT FEMORAL STEM KWA SMITH AND NEPHEW 71357007 06AM02738B
    99904 SMITH AND NEPHEW MODULAR FEMORAL HEAD FEMROAL HEAD KXA SMITH AND NEPHEW 74122546 10033

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R| S