Class I Recall: “Serious Adverse Health Consequences”
In total, 3,662 shoulder replacement devices have been recalled, over a particular concern that the implant’s humeral tray can fracture at far higher rates than were initially publicized:
- Comprehensive Reverse Shoulder System Humeral Tray
- Model #115340 (full list of lot numbers)
- Manufactured between August 25, 2008 to September 27, 2011
- Distributed between October 2008 and September 2015
- 3,662 shoulder replacement devices
After being notified of Zimmer Biomet’s recall, the US Food & Drug Administration classified the measure as a Class 1 action, the most serious form of recall. Class 1 recalls are reserved for medical devices that pose a “reasonable probability” of “serious adverse health consequences.” The FDA has taken a clear position on Zimmer Biomet’s shoulder replacement, all but labeling the device an unreasonably dangerous implant.
Zimmer Faces History Of Shoulder Implant Problems
Headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in medical devices, focusing on implants and orthopaedic devices. Originally a spin-off of pharmaceutical giant Bristol-Myers Squibb, Zimmer focused exclusively on joint replacement technology until the company’s portfolio was expanded in 2015 through the acquisition of orthopedic device company Biomet. In purchasing Biomet, Zimmer also gained access to the company’s suite of shoulder replacement devices, including the now-recalled Comprehensive Reverse Shoulder.
Zimmer Biomet’s Comprehensive Reverse Shoulder is an implant designed to restore arm movement in patients who have developed severe arthropathy, a form of shoulder arthritis, but have not experienced improvement after previous shoulder joint replacement procedures. The procedure is commonly performed for patients who have suffered massive rotator cuff tears.
High Failure Rate In Biomet Shoulder Led To 2011 Recall
This isn’t the first time that the Comprehensive Reverse Shoulder is being recalled over serious safety concerns. Approved for sale in 2008, the Comprehensive Reverse Shoulder was initially developed and marketed by Biomet, a company only acquired by medical device giant Zimmer in 2015.
The product’s initial 2008 launch, however, was marred by controversy only three years later. In 2011, Biomet issued a Class 2 recall for the shoulder product after “receiv[ing] complaints regarding fracturing device.” As in the most recent recall, Biomet’s humeral tray component was identified as the problem behind a suspiciously high rate of fractures and implant failures.
Reverse Shoulder Lawsuit Ends In Settlement
Legal action followed quickly after, including a 2014 product liability lawsuit filed by a man who received two defective Comprehensive Reverse Shoulder replacements.
Shockingly, both of the man’s implants fractured inside his body, leading to painful and complex revision procedures, along with significant medical expenses, pain and suffering. The complaint, Alarid v. Biomet, was logged in the US District Court of Colorado on July 30, 2014. It was registered under the case number 1:14-cv-02667-REB-NYW.
Two Shoulder Implants “Fracture” In Same Patient
In his lawsuit, the man, a resident of Denver, says that he received his first Comprehensive Shoulder Replacement in 2009, after being diagnosed with a massive rotator cuff tear in his left shoulder. In further consultations, the Plaintiff’s orthopedic surgeon recommended reverse total shoulder arthroplasty, in which the shoulder’s anatomy is reversed. Biomet’s Comprehensive Reverse Shoulder device was used, in an operation on September 24, 2009. The procedure went well, court documents say, and no complications were reported.
That’s why, when a 2010 MRI showed severe joint arthritis in the Plaintiff’s right shoulder, he was quickly scheduled for a second reverse total shoulder arthroplasty. By July 22, 2010, the man had received two Biomet Comprehensive Reverse Shoulder devices, one in either arm. Their “defective” nature would only surface three years after placement, the man claims.
Three Years After Placement, Implants “Snap”
In a routine physical therapy session on July 30, 2012, the Plaintiff felt a strange “clicking sensation” in his left arm, which was immediately followed by pain. Seven days later, the man was back in his surgeon’s office, reviewing the results of a new CT scan. The image, according to the man’s orthopedic specialist, provided evidence that Biomet’s shoulder implant had failed. The device’s humeral baseplate tray had separated from the trunnion.
The patient was told he would need to undergo revision surgery. Within two months, the man underwent another invasive procedure, in which his left shoulder implant was removed and replaced. Visual inspection of the faulty device confirmed that his implant had “fractured at the joint between the trunnion and the baseplate,” court documents report.
Only six months later, the Plaintiff’s right-side shoulder implant would also fail, causing significant pain and leading to yet another revision procedure. After the operation, the man’s orthopedic surgeon confirmed that, just like the patient’s first Biomet shoulder implant, his other device had fractured at the joint between the trunnion and the baseplate. This time, however, the trunnion itself had “snapped off,” according to the complaint.
Mounting Fracture Reports Led To First Biomet Recall
After outlining his own history of debilitating shoulder implant failures, the man goes on to accuse Biomet of knowingly manufacturing a defective medical device. The company received numerous adverse event reports involving the product, Plaintiff claims, including notification of fractured baseplates and dislodged trunnion assemblies. In fact, the man says that Biomet even designed a special tool that surgeons could use to remove the implant’s trunnion after it had snapped off.
Despite these reports, and apparent knowledge that the Comprehensive Reverse Shoulder would fail at alarming rates, Biomet only chose to recall the product in 2010, more than two years after the device was first introduced to the market. More troubling, the company was already gunning for a renewed approval only one year after the implant’s serious problems led to its recall.
510(k) Allowed Implant Approval Without Safety Testing
The man continues to note that, in 2008, Biomet sought initial FDA approval for the Comprehensive Reverse Shoulder through the federal agency’s 510(k) clearance pathway.
While nearly all pharmaceutical drugs are rigorously evaluated for both safety and efficacy, many medical devices are not. In fact, some manufacturers are allowed to sell their devices on the open market based solely on the product’s “substantial similarity” to a previously-approved device. In effect, medical device manufacturers can circumvent safety and efficacy testing if their product is similar to an older one.
Biomet would again take advantage of this lenient approval pathway, known as 510(k), in seeking federal approval to return the Comprehensive Reverse Shoulder to the market in 2011, a little more than a year after the device was first recalled. As in 2008, FDA reviewers determined that the shoulder implant was “substantially equivalent” to a previously-approved device.
Denver Court Enters Judgment Against Biomet
After two years of litigation, Biomet agreed to settle the case, resolving the man’s claims with a $350,000 settlement agreement. Colorado District Judge Robert E. Blackburn entered a judgment in favor of the Plaintiff against Biomet, along with two of the company’s subsidiary divisions, Biomet Orthopedics and Biomet Manufacturing. The case was closed on February 29, 2016.
Now, a full ten months after settling the company’s first case over the Comprehensive Reverse Shoulder, the implant has been officially recalled for a second time – under strikingly similar circumstances. In both recalls, Biomet Zimmer has pegged the implant’s humeral tray as a particular cause for concern. Legal observers believe that thousands of patients may be eligible to file suit.
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