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Zimmer Biomet Shoulder Recall
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By Jane Mundy
The Zimmer Biomet Shoulder replacement device has been recalled for allegedly fracturing at a higher rate than stated in the shoulder replacement label. The FDA issued the Biomet Comprehensive Reverse Shoulder recall as a Class I, the most serious type of recall because this allegedly defective product can cause severe injury and even death. Product liability lawyers are investigating Biomet shoulder recall notices and defective product claims.
The FDA issued notification that Zimmer Biomet is recalling the Comprehensive Reverse Shoulder because these defective medical devices are fracturing at a higher rate than is stated in the labeling. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.
Zimmer Biomet Recalls Comprehensive Reverse Shoulder Replacement
The Comprehensive Reverse Shoulder is a shoulder replacement device that is surgically implanted to help restore arm movement. This device is beneficial for patients with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and previously failed shoulder joint replacement.
More than 50,000 Americans undergo shoulder replacement surgery each year to relieve joint pain. There are several types of shoulder replacement surgery, including reverse shoulder replacement. Reverse shoulder surgery is relatively new: the first implants were approved in 2004. This type of surgery switches the “ball-and-socket” in the shoulder, replaces the shoulder socket with a metal ball, cuts off the top of the arm bone and attaches a plastic cup. Since its approval some patients have complained of loosening, instability, and fracture of the “humeral tray” or baseplate of the shoulder replacement device.
In 2007 the FDA approved the Biomet Comprehensive Reverse Shoulder by way of its 510K protocols, which is less stringent than the usual premarket approval process. This ‘fast-track” process allows a device to come to market without the requirement—and benefit-- of human testing if a manufacturer can demonstrate that it is “substantially equivalent” to a previously-approved product.
The FDA designated the Biomet Comprehensive Reverse Shoulder recall as a Class I, the most serious type of recall because these devices can cause severe injury and even death. The recall Initiated on December 16, 2016 involves 3,662 Biomet Shoulder replacement devices.
Biomet Shoulder Recalls
The Humeral Tray Model 115340 units affected by the Zimmer Biomet shoulder replacement recall were distributed between October 2008 and September 2015. Implants made after September 2011 have “design enhancements that increase the strength of the device,” according to a statement from Zimmer Biomet.
Trade Name: Biomet Comprehensive Reverse Shoulder Humeral
Product Code: KWS, PAO
Lot Numbers: All lots with part number 115340; See full list of lot numbers
Distribution Dates: October, 2008 to September, 2015
Manufacturing Dates: August 25, 2008 to September 27, 2011
Devices Recalled: 3662
In 2010, three years after Biomet’s Comprehensive reverse shoulder was approved, the company recalled the humeral tray and locking ring components of the system. Biomet said the recall was initiated after receiving complaints that the device was fracturing after being implanted. The FDA labeled the recall as class II, meaning use of the device could cause temporary or reversible adverse health consequences. The agency terminated the recall in July 2011, but the FDA-determined cause remains pending on its website.
Biomet 2010 Urgent Medical Device Recall
In early 2016 a Colorado man settled his Biomet Shoulder Replacement lawsuit for $350,000. According to court documents, Alfonse Alarid received both shoulder replacements in 2009 and 2010. Within a few years both devices failed, causing him pain and loss of function. Alarid underwent revision surgery to remove and replace the allegedly defective devices. (Alfonse A. Alarid v. Biomet, Inc., et al., No. 14-2667)
Biomet Shoulder Replacement Lawsuit and Settlement
Zimmer Biomet Shoulder Legal HelpIf you have suffered a serious fracture due to a defective Zimmer Biomet comprehensive reverse shoulder system, you may be eligible for compensation for your pain, suffering, medical bills, and other damages. If you or a loved one has suffered similar damages or injuries, please fill in our form and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
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Zimmer-Biomet Shoulder: Buyer (Patient and Surgeon) Beware
May 25, 2017Minneapolis, MN: Shoulder replacement surgery is a well-established and should be a straightforward procedure, unless your orthopedic surgeon is implanting a Zimmer Biomet shoulder that has failed and you are unfortunate to have one or two of the 3,600 implants that have been recalled [READ MORE]
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April 22, 2017Washington, DC: The fact that Zimmer Biomet had its Comprehensive Reverse Shoulder approved without any human testing likely comes as a shocking surprise to many recipients of the device. And another surprise: the device was pulled from the market in 2010 after Biomet received complaints of fracturing. But it returned just one year later [READ MORE]
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