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Stryker Hip Replacement

Stryker Orthopaedics designed hip devices which allow surgeons to match each implant with each patient's unique anatomy. The Rejuvenate and ABG II modular-neck are examples of these total hip arthroplasty devices.

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The Stryker Rejuvenate and ABG II modular-neck hip stems are components of metal-on-metal hip replacement systems that connect the “stem” portion of the implant (that anchors the implant in the thigh bone) to the head or “ball” portion (that rests in the socket to complete the joint). Components are manufactured of a proprietary cobalt-chrome alloy developed by Stryker known as GADS (Gas Atomized Dispersion Strengthened) Vitallium.

According to Stryker, the devices are designed to give surgeons the ability to better match the implant with the patient’s anatomy. Each system comes with an array of options to fit different biomechanical needs, and were marketed as especially suited to cases where patients suffer from hip dysplasia, post-traumatic arthritis, and other deformities that pose challenges when fitting standard components. 1

Reports of problems with modular-neck hip stems led the company to voluntarily issue recalls of certain Stryker components.

Surgical Options for Stryker Implants

Metal on metal bearings can produce small metallic wear debris or corrosion can take place with the constant movement between the two metal surfaces.

Surgical options depend on the surgeon’s preferences and a variety of patient factors. Each surgeon can use the surgical approach for total hip arthroplasty with which he or she is most familiar. Also, patient positioning, prepping and draping, the skin incision, soft tissue dissection, and hip dislocation is often performed according to the surgeon’s preferred technique.

Each procedure will differ based on the essential preoperative planning. Optimal femoral stem fit, prosthetic neck length, angle and version can be more closely evaluated with the use of preoperative X-ray analysis. Patients and family members should be sure to talk with surgeons during the planning and preoperative analysis to ensure that they understand the choices the surgeon is making for them.

Stryker Implants: Rejuvenate and ABG II Systems

The Rejuvenate and ABG II modular systems were designed for primary and revision total hip arthroplasty, compatible with other Howmedica Osteonics (later Stryker Orthopaedics) products at the time of their introduction. The company recommends use with cementless implantation, meaning their design allows bone to knit itself to the implant rather than utilizing bone cement for fixation.

The systems are implemented in the following ways:

  • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
  • Rheumatoid arthritis
  • Correction of functional deformity
  • Revision procedures where other treatments or devices have failed
  • Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques

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Metal on metal bearings can produce small metallic wear debris or corrosion can take place with the constant movement between the two metal surfaces.

Stryker Metal-on-Metal Hip Complications

The modular neck femoral components provide an additional interface with the tapered junction that post-market research suggests may be a potential source of metal fretting and crevice corrosion. Metal on metal bearings can produce small metallic wear debris or corrosion can take place with the constant movement between the two metal surfaces. The increase in serum metal ion levels and metal hypersensitivity can result in an Adverse Local Tissue Reaction (ALTR), causing premature failure of the device through osteolysis, aseptic loosening, and pseudotumor formation.

General symptoms of metal-on-metal hip replacement can include hip or groin pain, local swelling, numbness, or changes in your stride and ability to walk. Patients also may experience some of the more serious problems below.

Symptom Description
Sensitivity Although relatively rare, patients who have total hip arthroplasty using metal-on-metal devices can develop a hypersensitivity reaction (skin rash). The cause is generally an allergic reaction to the alloys in the device or the cement used to affix the device to the bone. 2
Cardiomyopathy Another rare complication, cardiomyopathy (disease of the heart muscle) can develop in patients with either ceramic or metal device components. In some cases, the implant can be worn down, causing cobalt to enter the system and poison the patient. 3
Neurological changes Hip replacement surgery can affect the patient’s senses and even cause auditory and visual dysfunction. Although such changes are uncommon, there exists potential for a wide variety of problems. As with cardiomyopathy, some of those problems are related to cobalt toxicity, 4 while others may be related to nerve damage incurred during the surgery. 5
Psychological changes In some cases, patients can experience depression or cognitive impairment after a hip replacement. However, several studies have shown that postoperative psychological changes are generally rare and may be attributable to other factors. 6 7
Renal impairment Urine retention and possible kidney failure are possible effects of hip replacement surgery. According to at least one study, men who have previously had renal disease are especially likely to develop renal impairment after total hip arthroplasty. 8
Thyroid dysfunction Thyroid-related problems may crop up after hip surgery, including discomfort around the neck, general feelings of fatigue, increased weight and cold sensations. 9

Rejuvenate Modular Stem and Neck Hazards

Stryker UK issued a field notice warning doctors and patients about potential hazards resulting from Rejuvenate modular stems and necks.

  • Through corrosion and fretting near the modular neck junction, the devices could generate excessive metal debris and ions in nearby joint cavities.

  • Measuring oxygen levels throughout the heart

  • Certain patients could develop hypersensitivity or even allergic responses.

  • Body tissue touching the device may experience an Adverse Local Tissue Reaction (ALTR), potentially resulting in pain, necrosis or metallosis.

  • In addition, debris from fretting could lead to osteolysis.

Rejuvenate Hip Implant Problems

Rejuvenate Modular Stem and Neck conditions could require correction through additional revision surgery. 10

A forthcoming article in the Journal of Arthroplasty 11 indicates that there are signs of implant fracture as early as four weeks after the surgery. Corrosion is also evident at an early stage.

Previously, it was thought that the damage from the Rejuvenate implant took much longer to manifest, so the settlement only provided for revisions occurring after six months. This new study provides evidence that the onset of injury can, in some cases, be much quicker.

Fractures and corrosion occurring at this short time period in the process is a concerning issue for patients. The longer it remains in place, the more a faulty implant can continue causing muscle and nerve damage.

Follow-up exams can help identify and fix issues that have a negative impact on your body. Everyone with these implants is encouraged to consult their surgeon about your own potential risk.

Stryker Hip Replacement Recall

In June 2012, citing the risk of fretting and corrosion associated with the Rejuvenate and ABG II modular-neck hip stems, Stryker issued a voluntary recall for both lines of modular-neck stems.

Patients who may have the implants are encouraged to contact their surgeon to discuss treatment and revision options even if they are not experiencing symptoms. Under the terms of the Stryker hip recall, the company has offered to reimburse patients and surgeons for testing, treatment, revision surgery and other costs associated with the recall. Other manufacturers of metal-on-metal implants have issued similar recalls. 12

After facing serious complications, like hip failure and the need for revision surgery, some Stryker hip replacement recipients have filed lawsuits against the manufacturer. Early estimates of Johnson & Johnson’s cost for its ASR settlements are over $4 billion. Terms of early Stryker hip settlements have not been disclosed.

  1. Stryker Corporation. ABG™II modular anatomic reconstruction. (May 2007). Accessed Aug. 25, 2013. 

  2. Lohmann, Christoph H. et al. Hypersensitivity Reactions in Total Hip Arthroplasty. (Sept. 2007). Healio Orthopedics. Accessed Aug. 5, 2014. 

  3. Zywiel, M. G. et al. Fatal cardiomyopathy after revision total hip replacement for fracture of a ceramic liner. (Jan. 2013). The Bone & Joint Journal. Accessed Aug. 5, 2014. 

  4. Monitoring for potential toxicity in patients with metal-on-metal hip prostheses: advice for health professionals. (Sept. 21, 2012). NPS MedicineNews. Accessed Aug. 5, 2014. 

  5. Brown, Gabriel D. et al. Neurologic Injuries After Total Hip Arthroplasty. (April 2008). American Journal of Orthopedics. Accessed Aug. 5, 2014. 

  6. Brodie, L. J. and R. M. Sloman. Changes in health status of elderly patients following hip replacement surgery. Journal of Gerontological Nursing. (March 1998). Accessed Aug. 5, 2014. 

  7. Jagmin, M. G. Postoperative mental status in elderly hip surgery patients. (Nov.-Dec. 1998). Orthopedic Nursing. Accessed Aug. 5, 2014. 

  8. Dutta, Sumit. Post-Operative Urinary Retention in Elective Total Hip and Knee Replacement Surgery. (Dec. 2008). British Journal of Medical Practitioners. Accessed 5 Aug. 2014. 

  9. U.S. Food and Drug Administration. General Recommendations for Orthopaedic Surgeons BEFORE Metal-on-Metal Hip Replacement Surgery. (Updated Jan. 17, 2013). FDA.gov. Accessed Aug. 5, 2014. 

  10. Rana, Daniel. URGENT Field Safety Notice: RA 2012-067. (Jan. 22, 2013). Medicines and Healthcare Products Regulatory Agency. Accessed Aug. 5, 2014. 

  11. De Martino, I., et. al., Corrosion and Fretting of a Modular Hip System: A Retrieval Analysis of 60 Rejuvenate Stems, Journal of Arthroplasty, accepted for publication, 2015. 

  12. Stryker Corporation. Rejuvenate modular / ABG II modular-neck stem voluntary recall. (June 2012). Accessed Jan. 14, 2014.