Is There A Biomet Zimmer Class Action?
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.
FDA Reports Show History Of Failures, Legal Claims
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:
- Implant fracture
- Separation of device components
- Device dislocation
- Implant migration
- Implant material erosion
- Device instability
- Severe shoulder infections
- Adhesions and scar tissue formation
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.
How Reverse Shoulder Replacement Works
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.
Traditional Shoulder Implants Mimic Natural Anatomy
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.
Reverse Implants Invert Shoulder Anatomy
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:
- severe pain from shoulder arthritis
- loss of rotator cuff and / or tendon function
- unsuccessful prior shoulder replacements
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.”
Recalled Humeral Tray Is “Defective,” Patients Say
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.
Shoulder Implant Recalled Due To “Design” Issues
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.
3,000+ Shoulder Devices Pulled From Market
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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