“A high incidence of adverse tissue reactions has been reported with metal-on-metal bearings with large heads” in the all-metal hip implants, according to a chapter in a March 2013 lecture series that Ottawa Hospital-based orthopaedic surgeons Dr. Vikram Chatrath and Dr. Paul E. Beaulé wrote.
The abstract of their chapter in “Instructional Course Lectures,” a volume that the American Academy of Orthopaedic Surgeons publishes, further explains the complexity of performing revision hip implant surgery in the presence of osteolysis, which the U.S. Food and Drug Administration parenthetically and succinctly defines as “bone loss.”
The authors wrote, “Recent reports of lesions associated with metal-on-metal implants and trunnion corrosion with femoral head sizes larger than 32 mm suggest that other mechanisms of wear debris production may be present; observation alone may not provide adequate monitoring. Advanced imaging modalities, such as MRI, should be used along with routine radiography to assess soft-tissue involvement and the size of osteolytic lesions.”
Does the surgical solution seem routine? Do the complications seem minor? How about the costs of injury, financial and otherwise, which appear to be anything but innocuous?
Buttressing the pertinence of these questions was another metal-on-metal hip implant recall.
Citing rates of revision surgery, J&J’s DePuy Orthopaedics reportedly recalled in February its Adept metal-on-metal hip implant model, which had been sold overseas.
Domestically DePuy also recalled its ASR XL Acetabular Hip System in August 2010, as the FDA explained, “because of new, unpublished data from the UK joint registry indicating the revision rates within 5 years were approximately 13 percent.”
Before that, Zimmer Inc. announced in July 2008 that it would “suspend marketing and distribution of the Durom Cup in the U.S., while we update product labeling to provide more detailed surgical technique instructions and implement a surgical training program for U.S. surgeons,” issues that loomed over device failures.
No wonder metal-on-metal hip implant lawsuits have been filed by patients who have sought to recover damages for losses economic and otherwise. The litigation is definitely much ado about something.
Elevated failure rates of metal-on-metal hip implants have done their share of damage. Surgeons have had their hands full — let’s deal with health insurance in another space — treating device-failure complications, to include metallosis, a condition derived from the release of metal particles into the tissue.
As a team of physicians based in The Netherlands wrote for Hip International in the fall of 2012, focusing on the all-metal large-diameter surgical hip replacements, “Metal ion release due to wear may cause osteolysis, pseudotumours and necrosis.”
Further, concluding that they “do not advocate” the use of a particular Zimmer metal-on-metal hip implant model, researchers in The Netherlands also wrote, “Lack of bone ingrowth and the presence of ARMD (adverse reaction to metal debris) seem to contribute to a high failure rate of the Durom LDH THA.”
The U.S. Food and Drug Administration recommended that orthopaedic surgeons, following metal-on-metal hip replacement surgery, “pay close attention to signs of the following local and systemic symptoms or complications associated with metal-on-metal hip implants”:
• Hypersensitivity (allergic type reaction)
• Osteolysis (bone loss)
• Aseptic lymphocytic vasculitis-associated lesions (ALVAL) (histologic reaction in surrounding tissue)
• Soft tissue mass (fluid-filled or solid soft tissue mass around the replaced joint that is diagnosed radiologically)
• Femoral neck fracture (for resurfacing systems)
Adverse reactions are not as rare as one might think. Addressing their study of large-diameter metal-on-metal total hip replacements, the British Hip Society and the British Orthopaedic Association reported, almost two years ago to the day, the following device-failure rates: “The presented results show a higher than anticipated early failure rate. These range from 21 percent revision rate at 4 years (potentially rising to 35 percent if all currently known painful implants progress to revision) to 49 percent at 6 years for the ASR XL device. Other devices have a revision or impending revision rate of 12-15 percent at 5 years.”
The recently recalled foreign-marketed Adept design notwithstanding, patients may be entitled to compensation if they have undergone revision surgery or merely have suffered complications related to the following metal-on-metal hip implants:
• Biomet M2a Hip Implants
• Biomet M2a-Magnum
• Biomet Regenerex
• Birmingham Hip Replacement
• Birmingham Hip Resurfacing (BHR) system
• DePuy ASR XL Acetabular System
• DePuy ASR Hip Resurfacing System
• DePuy Pinnacle Acetabular Cup System
• DePuy PINNACLE ULTAMET Metal Liner
• Portland Orthopaedics Ltd. M-COR Modular Hip System
• RingLoc + Modular Acetabular System
• Stryker Hip Implants
• Wright CONSERVE Total Resurfacing Hip System
• Wright PROFEMUR Hip Implant
• Zimmer Durom Cup
• Zimmer Continuum Acetabular System
Operating in all 50 states, the medical device attorneys at Reich & Binstock want to help patients who have suffered adverse reactions that may be related to their metal-on-metal hip implants. For a free consultation with an experienced personal injury attorney, send an electronic request for free initial legal advice through www.reichandbinstock.com or call the law firm toll-free at 1-866-LAW-2400.
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