Stryker Orthopaedics is one of the largest global orthopedic and surgical device companies with an estimated yearly revenue of $9 billion. Stryker’s most well-known products are likely the knee joint replacement devices but they manufacture a number of other orthopedic devices, including hip replacement hip implants – some of which have resulted in numerous injuries.
The Stryker corporation’s hip implants included the Rejuvenate and ABG II Modular-Neck hip stems which were approved in 2008 and 2009 but subject to a warning notification and voluntary recall in 2012 after multiple adverse events had been filed with the Food and Drug Administration.
The devices were intended to be safer and longer lasting for “younger” patients with active lifestyles. They were constructed of two sections, one of a cobalt and chromium alloy, the other coated with titanium. Though the implants were designed to resist corrosion with exceptionally hard metals, both the ABG II and Rejevinate hip devices have caused release of metallic debris into the surrounding tissue – resulting in a need for many patients to have revision surgeries.
Urgent safety warnings were issued by the company in 2012 and the devices were recalled shortly thereafter, but many patients had already been injured and patients were never warned directly by the company about the risk of adverse events.
ABG II Modular Neck Performance Claims
Stryker claimed that their ABG II Modular Neck hip stem would provide patients with the following:
- Primary Stability – Stryker claimed that the anatomical shape of the ABG II Modular Neck hip stem followed the contours of the patient’s femur, making the medical device exceptionally stable. Stryker stated, “This results in excellent clinical performances over time”
- Even Load Transfer – The ABG II Modular Neck hip stem’s three-dimensional conformity with the patient’s femur was claimed to allow for weight to be distributed evenly, resulting in natural and stable bone stress levels.
- Highly Customizable – The Stryker ABG II Modular Neck hip system offered a wide variety of sizes, with 8 right stems, 8 left stems, and 10 modular neck component for a choice by the surgeon to fit the system to each patient. Stryker claimed that this made the ABG II Modular Neck hip system particularly well-suited for younger patients seeking a wide range of motion.
- Encourages Bone Remodeling – Stryker claimed that the re-establishment of anatomically-correct stress and weight distribution would encourage healthy bone remodeling around the prosthesis, while preventing bone resorption. Stryker stated, “As a consequence, healthy bone stock is maintained around the implant in the long-term and a stable firmly-fixed total hip replacement is achieved”
- Prevents Erosion and Fretting – The Stryker ABG II Modular Neck hip stems were made of proprietary Stryker materials, all of which were said to be extremely hard and durable. Stryker’s ABG II Modular Necks were made of Gas Atomized Dispersion Strengthened (GADS) Vitalium. This material was a new cobalt and chromium alloy developed by Stryker, and the company claimed it featured “high performances in term of corrosion resistance and improved fatigue strength” for ABG II Modular Neck system patients. The other section was coated with titanium, a metal known for its hardness.
Stryker ABG II Side Effects
The Stryker hip implants can cause side effects in some patients such as:
Modular Neck Erosion resulting in:
- Metallosis – metal poisoning in surrounding tissue due to debris
- Necrosis and osteolysis – death and dissolution of bone and other tissue in the joint area due to metallosis
- Joint destabilization – erosion of the joint resulting in difficulty moving, muscle wasting and pain
Thousands of patients have been forced to undergo revision surgery and many have required reconstruction surgery due to the implant’s failure. The second procedure to repair a joint failure is often much more painful and requires a much longer recovery time. This results in significant pain, inflammation and a higher risk of infection.
Faulty Stryker Hip Design
Like many other hip implants on the market, the ABG II device was approved under the Food and Drug Administration’s (FDA) 510(k) Premarket Notification Process allowing the manufacturer to avoid costly clinical trials. The Stryker devices did not undergo implantation in humans before being released onto the market.
By the time post-market adverse event reports began piling up, hundreds had already been injured, and Stryker did not notify patients directly, instead “encouraging” physicians to do so.
Some of the Stryker claims for the ABG II device held true, the implants were still subject to metal corrosion, resulting in numerous injuries within the three short years the product was on the market. Many patients suffered from metallic deposits into surrounding tissue, while others suffered because the device became unstable as it corroded.
Consequently patients with failing hip implants required revision surgery. Some patients also required reconstruction to repair bone tissue that had degraded due to metallic debris. One woman was forced to undergo six total surgeries to repair damage caused by a Stryker device.
Stryker Hip Implant Lawsuits
Stryker faces over 4000 lawsuits in federal, state and local courts due to the ABG II and Rejuvenate Modular Neck Stem hip systems. As few as 12 of those lawsuits may have been settled and more are accruing each week. A 2013 regulatory document filed by Stryker indicated that the company expects to spend up to $1.3 billion on lawsuit settlements for both hip devices.
- CBS. (29 June 2012). FDA Panel Finds Little Use for Metal-on-Metal Hip Implants. CBS News. Accessed 07 October 2014 https://www.cbsnews.com/news/fda-panel-finds-little-use-for-metal-on-metal-hip-implants/
- FDA (6 July 2012) Recall — Firm Press Release, Stryker Initiates Voluntary Product Recall of Modular-Neck Stems. US Food and Drug Administration Safety. Accessed 07 October 2014. https://www.fda.gov/safety/recalls/ucm311043.htm
- FDA. (2014). Information for Orthopaedic Surgeons. US Food and Drug Administration Medical Devices. Accessed 07 October 2014. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241667.htm
- HMP, (2013), ABG II Hip Stem Recipient First to Sue Howmedica/Stryker in Federal Court, Harris Martin Publishing, Accessed on 07 October 2014 https://harrismartin.com/article/15949/
- Hollmer, M., (18 December 2013), Stryker agrees to settle four metal hip lawsuits as hundreds more loom, Fierce Medical Devices, Accessed on 07 October 2014 https://www.fiercemedicaldevices.com/story/stryker-agrees-settle-four-metal-hip-lawsuits-hundreds-more-loom/2013-12-18
- Hollmer, M., (19 March 2014), Stryker, slowly but surely, settles 8 more metal hip lawsuits, https://www.fiercemedicaldevices.com/story/stryker-slowly-surely-settles-8-more-metal-hip-lawsuits/2014-03-19
- Meneghini, R. M. , Evaluation of Painful total Hip Replacements Modular Metal taper Junctions. Accessed 07 October 2014 https://literature.ortho.stryker.com/files/NL12_NA_HP_433.pdf
- News Medical (2014) Hip Replacement History. News Medical Net. Accessed 07 October 2014. https://www.news-medical.net/health/Hip-Replacement-History.aspx
- PRWeb, (08 September 2014), As Stryker Hip Recall Litigation Grows, Coalition Urges FDA to Encourage Development of Medical Device Registries, Digital Journal, Accessed on 07 October 2014 https://www.digitaljournal.com/pr/2171999
- Reinberg, S. (27 June 2012). FDA Probing Safety of Metal-on-Metal Hip Implants. HealthDay. Accessed 07 October 2014 https://health.usnews.com/health-news/news/articles/2012/06/27/fda-probing-safety-of-metal-on-metal-hip-implants?s_cid=rss:fda-probing-safety-of-metal-on-metal-hip-implants
- Singer, S., (27 January 2013), Artificial hips corrode, poisoning some patients, local lawsuits say, Palm Beach Post. Accessed on 07 October 2014 https://www.palmbeachpost.com/news/lifestyles/health/artificial-hips-corrode-poisoning-some-patients-lo/nT7jf/
- Stryker. (June 2012). Rejuvenate Modular / ABG II Modular-Neck Stem Voluntary Recall. Accessed 07 October 2014. https://www.stryker.com/en-us/products/Orthopaedics/modularneckstems/index.htm
- Stryker. (5 July 2012). Field Safety Notice RA2012-067. Accessed 07 October 2014 https://www.mhra.gov.uk/home/groups/fsn/documents/fieldsafetynotice/con171937.pdf
- Stryker, (2007), ABG II Modular Anatomic Reconstruction, Stryker SA, Accessed 07 October 2014 https://www.rpa.spot.pt/getdoc/c504d4dc-4055-4fca-9410-c0f107982f22/ABG-II-Modular-Rationale-and-Surgical-Technique-%28S.aspx