One of the top manufacturers of hip replacement surgery devices, Stryker Orthopaedics has faced frequent scrutiny over complaints concerning their hip implant devices. Between 2000 and 2010, Stryker had more voluntary recalls than any other leading manufacturer of hip implants—forty percent of all voluntary recalls in that time.
In addition to frequent recalls, Stryker has been the subject of numerous lawsuits involving their hip implant devices. Most recently, Stryker has been criticized for their LFIT V40 femoral heads, which have been found to have an early failure rate.
June 3, 2008: The FDA Approves Rejuvenate
After a little less than a month of review, the FDA deems that Stryker’s Rejuvenate Modular Hip System does not require a premarket approval application and allows Stryker to begin marketing the device.
January 6, 2009: Stryker Issues a Class 2 Device Recall for Citation Hip Stems
Upon discovering that their Citation TMZF HA Hip Stem is not meeting their testing requirements, Stryker sends an “Urgent Product Recall” to healthcare professionals. In the letter, Stryker asks healthcare professionals to check their inventory for the affected devices and highlights some of the potential risks of the faulty hip stems. A total of 1,628 hip stems are involved.
November 4, 2009: The FDA Approves ABG II
Following the approval of the Rejuvenate device, the FDA reviews Stryker’s ABG II Modular Hip Stem from August to November and ultimately determines that it, like the Rejuvenate, does not require a premarket approval application and can now be marketed.
March 1, 2011: Stryker Issues a Class 2 Device Recall for Accolade Hip Stems
After finding “grit blast media” in the drive holes of certain Accolade TMZF Plus Hip Stems, Stryker recalls 44 of the devices. The company attributes the issue to employee error.
April 2012: Stryker Issues Safety Notice on Rejuvenate and ABG II
Stryker sends out an “Urgent Field Safety Notice’ to healthcare professionals warning them of potential risks involving the Rejuvenate and ABG II modular-neck systems. In the notice, Stryker acknowledges that they have received reports of the devices failing and “excessive metal debris and/or ion generation.” Stryker also states that for some Rejuvenate and ABG II patients, this may result in a need for a revision surgery.
July 6, 2012: Stryker Voluntarily Recalls Rejuvenate and ABG II
After finally accepting the safety concerns over the Rejuvenate and ABG II modular-neck systems, Stryker issues a voluntary recall of both products. The company attributes the recalls and the termination of all distribution of these devices to the potential risk of “fretting and corrosion at the modular neck junction,” which could contribute to a range of complications, including metal poisoning or metallosis. The recall comes in the face of many reports of complications to the FDA, and is followed by a wave of lawsuits from Stryker hip implant patients.
November 3, 2014: Settlement Reached on Rejuvenate and ABG II Lawsuits
After four months of negotiations, Stryker agrees to a global settlement program regarding the Rejuvenate and ABG II hip implants. The settlement is reached on behalf of an estimated 3,000 patients who had the devices implanted and ultimately had revision surgery to remedy the complications from issues with the devices. With no overall cap or fixed fund to the settlement agreement, Stryker’s ultimate payments in the settlement are expected to exceed $1 billion.
August 24, 2016: Health Canada Recalls LFIT V40
Citing a “higher than expected number of complaints received” concerning Stryker’s LFVIT 40 femoral heads, Health Canada makes the decision to recall specific lots and certain sizes of the device manufactured prior to 2011. They are the first, and so far only, country to officially recall the LFIT V40.
August 29, 2016: Stryker Sends “Urgent Medical Device Recall”
Stryker quietly sends a letter titled “Urgent Medical Device Recall Notification” to healthcare professionals, urging orthopedic surgeons to follow up with patients who received one of the LFIT V40 devices in the same lots that were recalled by Health Canada. In the recall notification, Stryker lists excessive metal debris as a potential risk of the LFIT V40.
No formal recall press release is issued during this time, but many predict that it won’t be long before Stryker definitively recalls the LFIT V40 femoral heads in question.
September 27, 2016: Australian Government Sends LFIT V40 Hazard Alert
In response to the letter sent by Stryker on the potential risks of the LFIT V40, the Australian Government Department of Health’s Therapeutic Goods Administration (TGA) issues a Hazard Alert. In the alert, the TGA advises orthopedic surgeons to follow up with their LFIT V40 patients, as directed by Stryker, and also advises patients who received the device to contact their surgeon if they feel certain symptoms, including instability, inflammation, unexpected pain and loss of mobility.
December 19, 2016: Agreement Reached for Additional Rejuvenate and ABG II Legal Compensation
Two years after their initial settlement agreement, Stryker expands their settlement agreement to include patients who had surgery and received the Rejuvenate or ABG II modular-neck devices later than November 3, 2014. This provides compensation to an additional two years of patients who ultimately had surgery to have their Stryker hip implant devices removed. Though it is finalizes much of the legal activity surrounding the Rejuvenate and ABG II hip implant devices, some lawsuits still remain.
Stryker Hip Lawyer
Many lawsuits have been filed against Stryker for their hip implant devices, including the Stryker LFIT V40, and the harm that has been linked to them.
If you or a loved one was given a Stryker hip implant device during hip replacement surgery, and feel that you have experienced negative effects as a result, please don’t hesitate to contact us to discuss your legal options.
During your no-fee consultation, our attorneys will answer your questions, outline your rights and options, and discuss whether you may be eligible for financial retribution from your adverse outcome.