After receiving numerous reports of debilitating fractures, Zimmer Biomet has recalled over 3,000 shoulder implants:
Affected patients are at an increased risk of experiencing implant fracture, revision surgery, infection and even death. Legal action may be possible.
In light of mounting failure reports, Zimmer Biomet has chosen to remove its Comprehensive Reverse Shoulder implant from the market, asking healthcare providers to “quarantine” their remaining stock and ensure that no more patients are implanted with the device.
These implants are dangerous. The US Food & Drug Administration has left little doubt that Comprehensive Reverse Shoulder devices appear to fracture at a troubling rate, identifying Zimmer Biomet’s recall as Class I, a category of recalls reserved for the most serious safety risks.
Now, injured patients are beginning to step forward, filing product liability lawsuits against Zimmer Biomet, the device’s manufacturer. As the FDA makes clear, shoulder implant fractures can lead to devastating health consequences. At the least, most people who suffer an implant failure will require invasive revision surgeries. Hundreds of patients may be facing extreme medical expenses, even as they struggle to deal with severe pain and emotional suffering.
These severe injuries, however, could have been prevented, patients claim. In fact, the Comprehensive Reverse Shoulder’s original manufacturer issued an earlier recall, in 2010, under extremely similar circumstances. This previous recall, initiated on September 13, 2010, came after Biomet received “complaints regarding fracturing of the device.” Despite the safety issue, Biomet’s shoulder replacement device returned to the market just one year later. Biomet was purchased by medical device giant Zimmer in 2015, forming the conglomerate Zimmer Biomet.
Nearly seven years after the device was first recalled, Zimmer Biomet has decided to pull the Comprehensive Reverse Shoulder off the market again. Just as before, the company has cited a “higher than expected rate of fracturing” as an explanation. There is, however, one major difference in this new recall. As the FDA notes, Zimmer Biomet appears to have conceded that design-related issues are at the heart of the shoulder implant’s fracture rate.
While a number of product liability complaints have already been filed over Zimmer Biomet’s Comprehensive Reverse Shoulder, these claims are being filed as individual injury lawsuits. Several of these lawsuits surfaced after the device’s first recall in 2010, Zimmer Biomet’s more recent recall has sparked a new wave of claims.
At least one of these shoulder implant lawsuits has reached a resolution. In February of 2016, Biomet agreed to settle a case, filed in a Denver federal court, in which a patient claimed that he had suffered implant fractures with two separate Comprehensive Reverse Shoulder devices. Court records from the US District Court of Colorado show that Biomet paid the man $350,000 to resolve his claims. This lawsuit, however, had been filed nearly two years earlier, in July of 2014, well before the implant’s most recent recall.
Legal observers are not yet aware of other settled claims, but the fact that many additional lawsuits have only come to light in FDA adverse event reports, rather than court records, may suggest that Zimmer Biomet has entered confidential settlement agreements with other plaintiffs. In fact, medical device reports submitted to the federal government suggest that Zimmer Biomet has faced numerous Comprehensive Reverse Shoulder lawsuits over the years.
One recent lawsuit, mentioned in a 2017 FDA medical device report, claims that a patient’s implant failed only 31 days after implantation. In a 2015 adverse event report, another man who has chosen to file suit against Zimmer Biomet reports a similar fracture, with one of the device’s screws breaking apart inside the body, leading to significant pain and revision surgery. A third complaint, submitted to FDA in August of 2016, repeats nearly identical allegations, suggesting that the patient’s implant shattered inside the shoulder.
To date, the FDA has received more than 100 adverse event reports involving the Comprehensive Reverse Shoulder. In these complaints, patients and healthcare providers describe numerous forms of injuries:
Despite this long list of potential complications, nearly 17% of these reports mention device fracture as the primary problem. In fact, many of the reports list the same issue – fracture of the device’s humeral tray – that inspired the shoulder implant’s recall in the first place.
Around 53,000 US patients undergo shoulder replacement procedures every year, the American Academy of Orthopaedic Surgeons reports. Shoulder replacement is a common treatment for patients who have developed severe shoulder pain due to arthritis, in which the shoulder joints become inflamed and impair the shoulder’s range of motion, or after traumatic injuries.
The majority of patients will receive traditional (or “anatomic”) implants, which attempt to mimic the shoulder’s natural anatomy. After removing damaged portions of the shoulder’s bony socket, surgeons will install a new cup, generally made from plastic, to fill the space and function as an artificial socket.
Meanwhile, the top of the arm’s long bone (humerus) is removed and replaced with a metal ball. Just like the implant’s plastic socket, this metal ball mimics the shoulder’s natural humeral head in both appearance and function. The metal ball is attached to a stem that can be inserted into the arm bone. Once the ball and socket have been fit together, the newly-reconstructed shoulder is able to move much like it did before surgery.
Traditional implants, though, aren’t right for everyone. In order to work like a normal shoulder, patients with anatomic replacements need functional rotator cuff muscles and tendons.
People who have suffered serious rotator cuff injuries need a different option: reverse shoulder replacements. In this procedure, surgeons literally reverse the shoulder’s anatomy. The device’s metal ball is implanted into the shoulder socket itself, rather than at the top of the arm’s long bone. Likwise, the implant’s synthetic socket component is attached to the humerus, instead of being used to replace the shoulder’s natural socket. With this configuration, patients can harness the arm’s deltoid muscle, rather than the rotator cuff, to initiate and control movement.
This is how the Comprehensive Reverse Shoulder system, first developed by Biomet during the mid-2000’s, works. The device was designed to improve arm mobility in patients who have lost a significant amount of muscle function in the shoulder, which can make traditional shoulder replacement techniques unfeasible. As a reverse shoulder implant, the Comprehensive Reverse Shoulder was only indicated for specific patients:
Now, the device has been recalled, after multiple patients experienced sudden and debilitating implant failures. As we noted earlier, the FDA has labeled this action a Class I recall, indicating that the device’s use “may cause serious injuries or death.”
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:
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.
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.
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.
The Comprehensive Reverse Shoulder’s true problem, however, appears to originate from a specific component of the orthopedic implant: the shoulder replacement’s humeral tray. In fact, the recall issued by Zimmer Biomet technically relates only to this one component, rather than the entirety of the company’s implant. While Zimmer has yet to admit that this component is defective, a number of reports have surfaced suggesting that the Comprehensive Reverse Shoulder can fracture inside a patient’s body – as the device’s humeral tray breaks away from a second component, the trunnion.
The implant’s humeral tray acts like a cap for the device’s humeral stem, a metal bar that extends downward into the arm’s long bone. The tray and stem are connected by means of a trunnion, a sort of pin used to mount one component on the other. Set inside the humeral tray is a bearing component, a hollow cup that functions like the shoulder’s natural socket, allowing the implant’s ball to move freely. Remember that the shoulder’s anatomy is reversed in this scenario, with the device’s ball implanted in the shoulder’s glenoid bone and the socket affixed to the arm bone.
In one lawsuit, a patient from Denver received two Comprehensive Reverse Shoulder implants within the span of a single year. After only three years of usage, both of the man’s implants had fractured, with the device’s humeral baseplate detaching from the implant’s trunnion. These device failures, the Plaintiff claims, aren’t isolated events. Biomet has received “multiple adverse reports” describing similar fractures, the man writes, indicating that the company’s shoulder implant is defective, both in design and manufacturing. Recent statements from the US Food & Drug Administration, along with Biomet Zimmer itself, seem to support the patient’s contentions.
In its official notice of the recall, published on February 11, 2017, the FDA explicitly provided an explanation for the recall, which had been supplied to the federal agency by Biomet Zimmer:
“Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.” [emphasis added] Subsequent federal investigations appear to have affirmed Biomet’s own findings. In a section titled “FDA Determined Cause,” health regulators have identified “Device Design” as the reason for the shoulder implant’s increased fracture risks.
The Comprehensive Reverse Shoulder was not a widely-used product. In fact, Biomet Zimmer’s initial recall, issued on December 15, 2016, covered only 3,662 implants manufactured between August of 2008 and September 2011. FDA records suggest that the company waited a full five days before notifying federal regulators of the recall. The manufacturer has now sent sales representatives to collect the affected implants. Patients who have already received Comprehensive Reverse Shoulder devices, however, have been provided little information on how to proceed.
Most of the affected implants have already been removed from the market. As of March 15, 2017, the FDA says that only a small number of Comprehensive Reverse Shoulder devices, 268 implants, remain in circulation. Their distribution, however, was fairly wide. According to federal regulators, Biomet Zimmer’s shoulder implant was sold in Canada, Australia, Chile, Colombia, Korea and the Netherlands, beyond the United States.
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Zimmer Biomet manufacturers' website: Responsive Statement on Recently Completed FDA Inspection (2016)