Stryker has voluntarily recalled its Rejuvenate and ABG II modular-neck stems that had been previously approved by the FDA in 2009. Modular-neck stems provide orthopedic surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics. The July 2012 recall by Stryker was initiated due to numerous complaints to the FDA regarding the potential risk of corrosion and fretting at or around the modular neck junction. This may result in adverse pain and/or swelling in or around your replaced hip.
Many of the Rejuvenate and ABG II modular-neck stems devices, which are supposed to last fifteen to twenty years, have failed in less than a year and a half. It also a blow to consumers because the hip implant devices were non-metal-on-metal, unlike the recent failures (replacement and chromium or cobalt poisoning) and recalls of Johnson and Johnson’s DePuyASR hip implants (Pinnacle) and Wright Medical’s Profemur Z hip replacement.
The FDA received an unusually high number of consumer complaints (MAUDE Adverse Event Report System) regarding Rejuvenate and ABG II modular-neck stems, claiming the following:
- Pain and tissue inflammation in the hip area that caused limping
- Difficulty or stiffness while walking
- Hip joints that squeaked, clicked, or grinded
- Uneven wear or failure of hip implants and/or the detachment of hip implant parts, which could result in bone fractures
- Need for subsequent hip surgeries, which not only removed the acetabular cup and the metal ball, but also had to replace the femoral stem (supposed to permanent and can cause femur fractures)
- Allergic reactions
FDA Warnings Issued to Stryker From 2005 – 2007
As a result of one investigation in 2007, the FDA sent a warning letter to Stryker regarding the defective practices stating, “This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with theCurrent Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation.”
Also in 2007, the FDA sent a second warning letter to Stryker: “[C]ustomer complaints have been received for squeaking/noisy ceramic on ceramic hip joints.”
Stryker Responds to FDA Pressure & Consumer Complaints
In April 2012, Stryker Orthopaedics issued an urgent Safety Alert for its Rejuvenate Modular Stems and Necks. The Safety Alert defined the potential hazards as follow:
- Excessive metal debris and/or ion generation. Fretting and/or corrosion at or about the modular neck junction may lead to increased metal ion generation in the surrounding joint space.
- Contact between metal ions and tissues and structures during an implant’s service life may result in an Adverse Local Tissue Reaction (ALTR), the inflammation of associated tissues experiencing immunological response (metallosis, necrosis, and/or pain). An ALTR may result in the need for revision surgery.
- Excessive fretting debris. Fretting may lead to increased metal debris in the joint space (concentration of debris exceeds individual patient threshold) resulting in osteolysis [bone dissolution]. Osteolysis may be asymptomatic and may result in the need for revision surgery.)
After Health Canada recalled the Rejuvenate Modular Hip implant in May 2012, Stryker Orthopaedics voluntarily recalled its Rejuvenate Modular Hip System in July 2012. The recall included Stryker’s Rejuvenate Modular and Stryker’s ABG II modular-neck hip stems.
The experienced defect product and product liability lawyers at Frachtman & Zimmerman defend and seek justice for victims of defective medical products. If you have experienced complications after being implanted with a Stryker Rejuvenate or a Stryker ABG II modular-neck stems, you may be able to file a claim for medical bills, lost wages, and other damages.
If you or a loved one has been implanted with a recalled Stryker Rejuvenate or a Stryker ABG II modular-neck stems and the product has failed, or if you are experiencing pain or swelling and would like to learn more about your legal rights--
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