Stryker Hip Recall
The Stryker Corp. is a medical technology company based in Kalamazoo, Michigan which manufactures a number of joint and bone replacement medical devices. Many of the Stryker medical devices have been successful but some of their hip replacement products have caused serious injury to a number of patients. Because of these injuries and potential threat of additional injuries, over the last several years, the company has been forced to issue numerous recalls of multiple types of Stryker hip implants.
Stryker hip recalls have previously been issued for:
- Stryker Rejuvenate Modular systems
- Stryker ABG II Modular systems
- Stryker LFIT V40 Femoral Head
Stryker Rejuvenate Modular and ABG II Hip Recall
The Stryker Rejuvenate Modular-Neck Stem hip replacement device was approved by the Food and Drug Administration (FDA) in 2008. This was followed in 2009 by the approval of the ABG Modular-Neck Stem in 2009. The devices were marketed for “younger” patients and were designed to closely mimic the anatomy and function of the human body.
Unlike other devices, these products were manufactured as “modular” units to make implantation easier for orthopedic surgeons and to allow for better product selection. They were intended to resist corrosion and metal fatigue – to provide a longer lasting implant without metal-on-metal construction which had already caused a number of injuries. Despite the attempt at improvement, the Stryker devices were still subject to a number of problems.
In June 2012, Stryker issued two “Urgent Field Safety” notices and published a report for physicians and surgeons regarding the proper implantation technique. The company acknowledged that the devices may be subject to potential failure due to metallosis, excessive metal debris, and ion shedding caused by corrosion at the neck junction. Despite the warning to physicians, no public notification was given.
By July of 2012, the Canadian health authority had recalled the devices and the FDA had received more than 60 serious adverse event reports regarding metal toxicity such as “Adverse Local Tissue Reaction” (ALTR), most of which required surgery. Post-market surveillance showed a higher than normal failure rate of both the Rejuvenate and ABG II hip stems and also revealed that patients experienced a higher than normal rate of side effects caused by corrosion and fretting of the components. Based on this data, Stryker issued a voluntary recall for both the Rejuvenate and ABG devices and halted global production and sales at the same time.
In August of 2012, Stryker finally urged physicians to inform their patients of the recalls and to encourage them to contact the company, but many patients had already experienced serious injury such as bone death and metal toxicity, requiring revision surgeries.
Stryker LFIT V40 Femoral Head Recall
Approved in 2000, Stryker Metal LFIT V40 Femoral Head is one component of a hip implant system which was designed to be used with the Stryker Accolade TMZF and Accolade 2 stems and is now also used with the Stryker Meridian and Citation stems.
An August 2016 “Urgent Medical Device Recall Notification” letter was sent to all surgeons implanting patients with the V40 LFIT device. A high number of reports had been received by the agency indicating that the devices may be subject to disassociation of femoral head from hip stem, fracture of the stem, corrosion of the trunnion, excessive metallic debris and numerous other complications caused by corrosion at the connection between the head and stem (trunnion).
The recall involved a number of lots manufactured before 2011 and included a potential 42,000 units. In May 2018, the recall was expanded to include additional lots manufactured between 2002 and 2011. Recent published studies have shown symptoms and failures of these metal heads may occur, even in lots not covered in the affected Stryker recall.
Stryker had previously manufactured another hip device which was used with the LFIT V40 Femoral heads, the Accolade TMZF which had also resulted in a number of injuries. Three temporary recalls were issued between 2009 and 2013 due to packaging and manufacturing issues but the device remains on the market and may also corrode in the same manner as other models.
Faulty Stryker Hip Design
The Stryker Rejuvenate and ABG II hip systems and the LFIT V40 Femoral heads are not typical “metal-on-metal” (MoM) but the device necks are constructed of cobalt and chromium. The neck stems are coated with titanium which causes a junction, where the two metals may grate on one another, generating metallic debris around the implant site.
Like many other hip replacement products, the Stryker devices were approved under the 510(k) Premarket Notification Process. This is an exemption allowed for medical devices that are “substantially similar to and not substantially different from” medical devices already on the market. The 510(k) process allows the manufacturer to avoid expensive clinical testing.
The Stryker products were not subject to clinical trials, consequently physicians and patients had to rely on post-market surveillance reports to identify problems and many patients had already been injured, suffered severe side effects or required revision surgeries by the time reports surfaced.
Stryker Hip Lawsuits
As a result of the Stryker hip recall and injuries caused by the medical devices, Stryker is facing a number of lawsuits for injuries caused by the hip implants. Many cases have already been settled but thousands remain or may be expected in federal, state and local courts.