Hip Implany Seminar

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  • On top of the femur is the femoral head, which is shaped like a ball.The “ball” or femoral head fits into the Acetabulum or “cup” on the side of the Pelvis.Articular Cartilage covers the surface of the ball and the cup. This Cartilage is a rubbery and slippery, which allows for the ball to rotate in the cup smoothly.The Human Hip is a ball-and-socket joint.The Hip is designed for a wide range of motion.The Hip is one of the most complex joints in your body, which requires healthy tissue among other things to function properly.
  • Hip Implany Seminar

    1. 1. DEPUY HIP IMPLANT SEMINAR<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    2. 2. DePuy Hip Implant SeminarAGENDA<br />Introductions<br />Engineering Analysis<br />Medical Analysis<br />Protecting Your Legal Rights<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    3. 3. Engineering Analysis<br />Mari S. Truman<br />
    4. 4. MARI S. TRUMAN<br />Graduated Magna Cum Laude in Biomedical Engineering.<br />Masters Courses in Mechanical Engineering at the University of Illinois.<br />Product Development Engineer for DePuy from 1980 – 1991. <br />Principal Engineer & Manager of OrthoBioMech, LLC – Orthopedic Device Development.<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    5. 5. Anatomy of the Hip Joint<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    6. 6. The smooth rotation of the ball as it glides in the cup is extremely important, because it allows for individuals to walk, run, climb, bend, and sit.<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    7. 7. Hip Biomechanics<br /><ul><li>Soft tissues: Muscles, ligaments & tendons
    8. 8. Support the joint
    9. 9. Guide the joint through range of motion
    10. 10. Soft tissue damage leads to joint instability
    11. 11. Instability alters biomechanics of the hip
    12. 12. Leads to alteration of other joints including knees, ankles and spine</li></ul>© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    13. 13. Design of DePuy’sMetal-on-Metal ASR Hip Implant<br />Force and Motion<br />Acetabular Cup<br />Femoral Head<br />Synovial Fluid<br />Friction and Wear<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    14. 14. 5 Unique Features in the ASR<br /> Made It Defective & Unsafe<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />Sub-hemispheric coverage of the ball.<br />Internal lip on cup.<br />Low clearance between the ball and the cup. <br />4. Thin cup.<br />5. One-piece cup construction combined with cementless implantation.<br /> <br />
    15. 15. Sub-Hemispheric Coverage<br />Cup coverage is less than 180°, that is, it covers less than half the ball.<br />180° arc<br /> Leads to easier dislocation of ball from cup, and to other problems.<br />Ball<br />Sub 180° <br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    16. 16. Internal Lip<br />Internal lip at perimeter further reduces ball coverage.<br />Hu, X Q; Jeffers, J; Roques, A; Taylor, A; Tuke, M: In Vitro Wear Study of MOM and COM Hip Prostheses with High Cup Angle. 2011, 57th AnnualORS Meeting, Poster No. 1128.<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    17. 17. Low Clearance<br /> Clearance <br /> about 70 to 100 microns <br /> vs.<br /> about 150 to 300 microns<br />Optimal<br />Excessive<br />Too Little<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    18. 18. Thin Cup<br />A thin cup is more easily deformed with impaction. This compounds the ASR’s problems with low clearance and sub-hemispheric coverage.<br />After Impaction<br />Before Impaction<br />Cup<br />Ball<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    19. 19. One Piece Construction<br /><ul><li>The cup of the ASR Implant is a single piece construction—it has no holes for viewing the hip socket through the cup.
    20. 20. This makes it difficult for the surgeon to confirm that the cup is fully seated in the socket during installation.
    21. 21. An improperly seated cup may loosen early and allow the cup to rotate into a non-optimal position, causing excessive wear.</li></ul>© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    22. 22. Head<br />Edge Loading<br /><ul><li>The result of the ASR’s 5 design flaws (e.g., sub-hemispherical coverage, internal lip, low clearance, thin cup, one piece constructions) is Edge Loading.
    23. 23. Edge Loading is the concentrated stress and contact at the rim of the cup that leads to excessive metal wear and the release of metal ions into surrounding tissue.</li></ul>© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    24. 24. DePuy Marketed ASR Without Conducting Clinical Trials<br />ASR design changes from prior FDA approved Metal-on-Metal hip implant designs were numerous and substantial.<br />Lab testing indicated cup deformation on installation and higher wear in high activity/high demand patients.<br />Lab testing in foreseeable mal-position orientations was not done prior to selling in the USA.<br />Correction of the design flaws and controlled comparative clinical studies were warranted prior to general release in the USA.<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    25. 25. Medical Analysis:<br />DePuy ASR Implant<br />Melissa Neiman, M.D., J.D.<br />
    26. 26. Melissa Neiman, M.D., J.D.<br />Received Doctor of Medicine degree from University of Texas Medical Branch.<br />Completed Neurosurgical residency at Parkland Memorial Hospital in Dallas, TX.<br />Practiced neurosurgery for 14 years. <br />Received Doctor of Law degree from University of Houston.<br />Practiced law since 2006, specializing in medical-legal cases.<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    27. 27. Primary Severe Complications: DePuy ASR Implant Patients<br />Severe groin, thigh and/or hip pain<br />Difficulty standing and/or walking<br />Crunching and/or popping noises<br />Limping or favoring one leg<br />Hip fractures or dislocation<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    28. 28. Secondary Severe Complications:Metallosis-Heavy Metal Toxicity<br />As metal-on-metal surfaces rub together, microscopic ions of chromium and cobalt are released into and around the joint space. <br />This results in elevated levels of chromium and cobalt in the hip area leading to METALLOSIS or Heavy Metal Toxicity. <br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    29. 29. Warning:Next slide is graphic.<br />
    30. 30. Metallosis: Localized Tissue Damage<br /><ul><li>Cytotoxicity
    31. 31. Inflammation
    32. 32. ALVAL (Aseptic Lymphocytic Vasculitis Associated Lesions)
    33. 33. Pseudo-tumors
    34. 34. Black tissue
    35. 35. Bone mass deterioration
    36. 36. Tissue and muscle necrosis
    37. 37. Bacterial infection
    38. 38. Brownish fluid collections</li></ul>© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    39. 39. Absorption of Chromium & Cobalt into the Bloodstream: Systemic Damage<br />Cobalt and chromium ions are absorbed into the bloodstream resulting in widespread damage to the body.<br />Signs and symptoms of systemic toxicity:<br />Fatigue<br />Headaches<br />Depression<br />Tinnitus<br />Hearing loss<br />Visual loss<br />Shortness of breath<br />Vertigo<br />Rash<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    40. 40. Effects of Cobalt Toxicity<br />Neurotoxicity<br />Damage to the nervous system.<br />Symptoms: tinnitus, vertigo, deafness, blindness, optic nerve atrophy, convulsions, headaches, peripheral neuropathy, cognitive decline.<br />Hypothyroidism<br />Deficiency of thyroid hormone.<br />Symptoms: fatigue, hair loss, weight gain, feeling cold.<br />Cardiomyopathy<br /><ul><li>Heart muscle disease with deterioration of heart function.
    41. 41. Symptoms: shortness of breath, arrhythmias or sudden cardiac death.</li></ul>© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    42. 42.
    43. 43. Detection of Chromium and Cobalt Toxicity<br />If you have a DePuy ASR implant, the chromium and cobalt levels in your blood should be tested every 3 months by your treating physician.<br />Normal blood levels of chromium and cobalt are each below 0.5 micrograms/liter (µg/L).<br />Chromium or cobalt levels above 5.0 micrograms/liter (µg/L) are considered toxic and closer surveillance may be necessary.<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    44. 44. Protecting Your Legal Rights<br />Dan McDonald, J.D.<br />
    45. 45. Dan McDonald<br />Partner with Parker McDonald, P.C<br />Tried over 150 cases to verdict. Achieved 81 verdicts or settlements of $1 million dollars or more.<br />Represented thousands of clients against medical device and pharmaceutical manufacturers.<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    46. 46.
    47. 47. DePuy Putting Patient Safety & Health First?<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    48. 48. Our Opinion – DePuy Was Grossly Negligent<br />Australian withdrawal – December 2009<br />March 6, 2010 – Letter Warning to U.S. Doctors – higher than expected failure rate<br />August 26, 2010 – ASR Recall from U.S. Market <br />As a result, in our opinion, DePuy’s conduct was unconscionable and DePuy is liable for punitive damages in every single case in which a patient was implanted with a ASR device from December 2009 to August 26, 2010.<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    49. 49. DePuy ASR is Deadly Dangerous!<br />Cr and Co – destroy bone and soft tissue.<br />Cr and Co – cause cancer, kidney failure, heart irregularities and chromosomal damage.<br />ASR Patients face a very serious medical situation.<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    50. 50. All ASR Patients Are At Grave Risk!<br />Our opinion – ASR Failure Rate will be nearly 100 %.<br />Our opinion – 90% of all ASR patients will require revision surgery.<br />All ASR patients are at risk for Metallosis and heavy metal systemic toxicity.<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    51. 51. Our Position With Your Surgeon<br />Not a medical malpractice claim – we will not sue your doctor for negligence.<br />Your Doctor – Financial Relationship with DePuy?<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    52. 52. Protect Your Legal Rights<br />Each individual with a DePuy ASR hip implant has a claim against DePuy.<br />If you have had revision surgery or revision surgery is scheduled, you should file your claim against DePuyNOW.<br />If you have not yet had a revision surgery, you NEED medical and legal monitoring for as long as you have your ASR implant.<br />We are NOT filing Class Actions<br />Statute of Limitations is RUNNING ON ALL CLAIMS!<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    53. 53.
    54. 54. Don’t Sign DePuy’s Release!<br />DON’T WAIVE YOUR MEDICAL PRIVACY RIGHTS! <br />DON’T WAIVE YOUR LEGAL RIGHTS!<br />DEPUYWILL NOT PAY OR REIMBURSE YOU FOR YOUR PAIN & SUFFERING, FOR ANY TEMPORARY OR PERMANENT PHYSICAL INCAPACITY YOU MAY EXPERIENCE OR FOR ANY MEDICAL COMPLICATIONS RELATED TO YOUR SURGERY.<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    55. 55. Parker McDonald & Harrison Davis Steakley Morrison <br />Vast Experience with Medical Devices and Defective Drugs.<br />Over 200 collective years of Personal Injury Trial Experience.<br />Hundreds of Millions of Dollars collected for victims of defective medical devices and defective drugs.<br />Most Experienced, Aggressive and Dynamic DePuy litigation and trial team in the country.<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />
    56. 56. IF YOU HIRE US<br />Contingent fee contract<br />No financial obligation for expenses or attorney’s fees at any time, unless we recover money for you from DePuy.<br />We will monitor your case and provide updates on an ongoing basis for as long as you have your DePuy ASR Implant.<br />We are always available – you will have our personal emails and cell phone numbers.<br />We are your lawyers – we will NOT refer your case to other lawyers.<br />© 2011 Parker McDonald, P.C.  All Rights Reserved. <br />

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