Zimmer Biomet Shoulder Replacement
Helping Patients Harmed by Zimmer Biomet Shoulder Replacement Device Failures
The Driscoll Firm, LLC, is investigating the failure of the Biomet Comprehensive Reverse Shoulder Humeral replacement device among those who had the device surgically implanted prior to its December 15, 2016, urgent recall.
Zimmer Biomet and the U.S. Food and Drug Administration (FDA) say the Comprehensive Reverse Shoulder Humeral device fractures at a higher rate than is stated in product labeling.
The Class I FDA recall targets 3,662 of the total shoulder replacement implants distributed from October 2008 to September 2015 under 300 lot numbers that include part number 115340.
A Class I recall is the FDA’s most serious category of recall. It means the agency has determined that use of the recalled device exposes patients to reasonable chance of serious injury or death.
Patients who have received a Biomet Comprehensive Reverse Shoulder Humeral in full shoulder replacement surgery are urged to contact The Driscoll Firm for a free consultation about their legal options.
Even if you have had no problems with the Biomet Comprehensive Reverse Shoulder up to this point, the acknowledged flaw in the device exists and you may require additional surgery to replace it. The Driscoll Firm has litigated and resolved defective medical device claims on behalf of thousands of clients across the country. We can work to ensure that you are properly compensated for your medical expenses, pain, suffering, and other losses.
Contact us today. We do not charge clients of defective medical device claims legal fees or costs until we recover money for them.
What Is the Threat of the Biomet Comprehensive Reverse Shoulder Implant?
The Biomet Comprehensive Reverse Shoulder is a surgical implant used as a total shoulder replacement to restore movement and relieve pain. It has been recommended and used for patients diagnosed with rotator cuff tears who have also developed a severe type of shoulder arthritis known as “arthropathy.”
Additionally, some patients with grossly deficient rotator cuffs whose previous shoulder joint replacement failed were subsequently implanted with the now-recalled Zimmer Biomet device.
The problem with the Comprehensive Reverse Shoulder implant is that it falls apart — “fractures” — more often and sooner that the manufacturer has stated it should be expected to.
A fracture in a shoulder implant will cause it to come loose within the patient’s shoulder. This will cause pain and may adversely affect shoulder mobility. Affected patients may require revision surgery (removal and replacement of the implant), which could cause serious adverse health consequences, such as:
- Permanent loss of shoulder function
- Infection
- Death
The FDA recall notice instructs medical providers to identify and set aside any affected devices until they can be taken by a Zimmer Biomet sales representative. There are no recommendations for specific patient monitoring related to this recall beyond existing protocols for following up on surgical procedures.
Previously, in 2010, the FDA issued a Class II recall for 45 of the new Zimmer Biomet Comprehensive Reverse Shoulder implants, which were in circulation in eight states: New York, Maryland, Virginia, Alabama, Texas, Oklahoma, Colorado and South Dakota. The recall was initiated because the manufacturer has received complaints about the device fracturing.
An FDA Class II recall indicates a situation in which use of the product may cause temporary or medically reversible adverse health consequences. The probability of serious adverse health consequences is considered to be remote.
Eventually, the Biomet Comprehensive Reverse Shoulder Humeral implant returned to the market until being withdrawn in the more recent and widespread recall. In a February 2017 update to that recall notice, the FDA says the device’s higher-than-anticipated rate of fracturing is “due to design.”
How The Driscoll Firm Lawyers Can Help
If you have received a Biomet Comprehensive Reverse Shoulder implant, The Driscoll Firm can help you seek compensation for your past and future medical expenses related to the device, and for your pain and suffering.
We can begin by helping you obtain your medical records and, through them, determine whether your shoulder replacement is a recalled Zimmer Biomet device. We will do this at no charge to you.
Many defective medical device cases become class action lawsuits combining similar claims, or multidistrict litigation (MDL), which combines multiple cases according to geography. As your attorneys, we can advise you of the pros and cons for joining ongoing litigation or pursuing an individual lawsuit.
If and when Zimmer Biomet offers to settle claims over its faulty shoulder implant (as usually happens), The Driscoll Firm will advise you about the terms of the offer and/or settlement of a class action or MDL, and the options available to you. Remember: The decision of whether to accept a settlement will be yours alone to make.
Contact Our Defective Shoulder Implant Lawyers Today
The Driscoll Firm has successfully resolved claims for thousands of clients in defective medical product cases from across the country. Our attorneys have served in leadership roles in numerous cases, including serving as class counsel, state liaison counsel and as members of committees of lawyers in charge of making key decisions about how a case proceeds.
If you believe that you or a loved one has received a Biomet Comprehensive Reverse Shoulder implant, it is important to take prompt action to plan for your future. Contact us today by phone or online to receive a timely, free and confidential consultation.
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