Stryker advises clinical examination on all patients with ABG II modular-neck or Rejuvenate system
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The hip implant systems Rejuvenate and ABG II modular-neck were recalled in June 2012 by Stryker. Recently on January 3, 2013, Stryker announced several important developments concerning these two recalled hip implant systems.
In a letter to surgeons, Stryker says that surgeons should consider conducting a clinical examination on all patients who had the ABG II modular-neck or Rejuvenate system implanted. Performing these clinical examinations are recommended on patients who have not even experienced any pain or swelling. Surgeons should also have follow up examinations on all affected patients.
Stryker has partnered with Broadspire Services, Inc., a third party claims administrator, to help manage any requests for reimbursements of costs relating to this recall. The company is going to reimburse patients for any revision surgery, treatment, testing and any other costs relating to the recall.
The potential hazards associated with the ABG II modular-neck hip stems and the Rejuvenate systems include corrosion and/or fretting about the modular neck junction which may lead to an increased metal ion generation in the surrounding joint space; the excessive metal debris and/or ion generation.
Patients may experience hypersensitivity and or an allergic reaction which can result in the need for revision surgery. An Adverse Local Tissue Reaction (ALTR) can occur when there is contact between metal ion and tissues and structures during an implant’s service life. ALTR is the inflammation of associated tissues experiencing metallosis, pain, and/or necrosis. Fretting may lead to increased metal debris in the joint space. This can then lead to osteolysis and then can result in the necessity for revision surgery.
Those who have been affected by this recall or have questions may wish to contact us our experienced attorneys with Childers Schlueter & Smith LLC, or at (800) 641-0098.
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Richard Schlueter,
Stryker,
voluntary recall of the Rejuvenate and ABG II modular-neck femoral hip systems,
Adverse Local Tissue Reaction,
ABG II modular-neck hip stems,
Stryker recall,
Broadspire Services,
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