BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY FRANCE CORAIL

    MDR report key: 3029233 · Received March 26, 2013

    Report

    Report Number
    MW5029542
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 26, 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) 2009. I RECEIVED THE DEPUY TOTAL HIP SYSTEM PINNACLE 100 ACETABULAR CUP SZ MM52. PRIOR TO SURGERY, I HAD PAIN IN THE BUTTOCK THAT RADIATED AROUND LATERALLY AND INTO MY GROIN. THE PAIN WAS SO SEVERE AT TIMES, THAT I COULD NOT WALK OR STAND. AFTER SURGERY, THE PAIN WENT AWAY BUT THEN IN THE (B)(6) OF 2010, I BEGAN EXPERIENCING INCREASING PAIN OVER THE HIP. I HAD AN ASPIRATION OF THE RIGHT HIP ON (B)(6) 2010. THEN, I HAD A RIGHT HIP ARTHROGRAM AND INTRA-ARTICULAR STEROID INJECTIONS ON (B)(6) 2010. I ALSO HAD ANOTHER RIGHT HIP ASPIRATION ON (B)(6) 2010. I HAD TO HAVE A REVISION OF MY RIGHT TOTAL HIP REPLACEMENT ON (B)(6) 2011, REQUIRING ADDITIONAL HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124209 DEPUY FRANCE CORAIL HIP IMPLANT KWA DEPUY ORTHOPAEDICS, INC. 20774157
    124570 DEPUY PINNACLE 100 ACETABULAR CUP SYSTEM METAL-ON-METAL HIP IMPLANT, ACETABULAR CUP KWA DEPUY ORTHOPAEDICS, INC. C48H91000
    124571 DEPUY APEX HOLE ELIMINATOR - PS HOLE ELIMINATOR JDI DEPUY ORTHOPAEDICS, INC. C82A91000
    124572 DEPUY PINNACLE METAL INSERT METAL INSERT, NEUTRAL 36MM ID X 52 MM OD KWA DEPUY ORTHOPAEDICS, INC. 2767483
    124573 DEPUY ARTICUL/EZE METAL-ON-METAL FEMORAL HEAD FEMORAL HEAD 36 MM +12, 12/14 TAPER JDI DEPUY ORTHOPAEDICS, INC. 282904

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S