Biomet Pays $350,000 to Settle Defective Shoulder Replacement Case

Defective Biomet replacement shoulder, showing the fractured baseplate and snapped of trunnion.
Defective Biomet replacement shoulder, showing the fractured baseplate and snapped of trunnion.

Biomet, Inc. agreed to pay $350,000 to a Denver man who had both shoulders replaced with defective Comprehensive Reverse Shoulder prostheses, only to have double revision surgeries after they both snapped and broke inside his body.

Plaintiff Alfonso A. Alarid accepted the settlement on Feb. 4, 2016, from defendants Biomet Inc., Biomet Orthopedics LLC and Biomet Manufacturing LLC, all based in Indiana. The case is Alarid v. Biomet,  Case No. 1:14-cv-02667-REB-NYW, US District Court for the District of Colorado.

The settlement was negotiated by plaintiff’s attorneys Jennifer E. Bisset, Bisset Law Firm of Denver, CO, and Gregory A. Hall, Law Office of Gregory A. Hall of Denver, CO.

On September 13, 2010 Biomet issued a recall notice for the defective Comprehensive Reverse Shoulder, including the two Comprehensive Reverse Shoulder devices that were implanted into the plaintiff’s left shoulder in 2009 and his right shoulder in 2010. According to Biomet, it issued the recall notice due to complaints it received about fracturing of the device at the joint between the trunnion and the baseplate.

Biomet’s Comprehensive® Reverse Shoulder is a Class II medical device, approved in 2008 pursuant to the FDA short-cut 510(K) process, instead of the more rigorous FDA “Premarket Approval” process. By September 2010 Biomet had received multiple adverse reports about the defective Reverse Shoulder and recalled it.

Alarid filed suit on July 20, 2014, alleging strict products liability, breach of express warranty, breach of implied warranty of merchantability and negligence.

Left shoulder replaced

His doctor told him on October 21, 2008, that he would need a left shoulder replacement because of a massive rotator cuff tear. Reverse shoulder replacement, or RTSA, is a surgical procedure that reverses the anatomy of the shoulder. It is designed so that the ball is attached to the shoulder blade (scapula) and the socket is placed on top of the upper-arm bone (humerus). By reversing the normal anatomy, the deltoid muscle, one of the stronger shoulder muscles and the only abducting muscle remaining in the shoulder, is given control to raise the arm.

Alarid had the left shoulder replaced on September 24, 2009. On July 30, 2012 Plaintiff was simply participating in physical therapy when he felt a clicking sensation in his left arm followed by immediate pain. A CT scan on August 6, 2012 showed that the humeral baseplate tray and trunnion of the Biomet Comprehensive® Reverse Shoulder had separated. On October 11, 2012, Dr. Schneider performed revision surgery to remove and replace the Biomet shoulder prosthesis.

A visual inspection confirmed that the device fractured at the joint between the trunnion and the baseplate.

Right shoulder replaced

On May 12, 2010 an MRI of Plaintiff’s right shoulder showed severe glenohumeral joint arthritis with labral tearing and irregularity with a large paralabral cyst along the posterior glenoid. On July 22, 2010, Plaintiff underwent surgery on his right shoulder, during which Dr. Schneider performed a reverse right total shoulder arthroplasty and implanted the second Biomet Comprehensive® Reverse Shoulder device.

On March 22, 2013, the plaintiff was simply getting up off the floor when he experienced right shoulder pain. On April 17, 2013, Dr. Schneider performed revision surgery on the right shoulder to remove and replace the defective Comprehensive® Reverse Shoulder prosthesis.

A visual inspection confirmed the device fractured at the joint between the trunnion and the baseplate, and that the trunnion had snapped off.

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High Fracture Rate Causes FDA Recall of Zimmer Biomet Shoulder Replacement

Photo of Zimmer Biomet Comprehensive Reverse Shoulder deviceThe FDA has issued a Class I recall, the most serious type of recall, for more than 3,600 shoulder replacement devices — the Biomet Comprehensive Reverse Shoulder Humeral Tray Model 115340. Use of these devices may cause serious injuries or death.

  • Product Description: Comprehensive Reverse Shoulder System Humeral Tray Model 115340
  • Product Code: KWS, PAO
  • Lot Numbers: All lots with part number 115340
  • Distribution Dates: October, 2008 to September, 2015
  • Manufacturing Dates: August 25, 2008 to September 27, 2011
  • Devices Recalled: 3,662

High fracture rate

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.

Biomet Manufacturing Corp., based in Warsaw, IN, is recalling the Comprehensive Reverse Shoulder because these 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.

No safety review

The FDA gave Bioment clearance to market the shoulder device through the short-cut 510(k) process, based on its similarity to a previously-approved device — but not a review of its safety or efficacy as would happen in a rigororous premarket approval application (PMA):

  • The Biomet Comprehensive® Reverse Shoulder – Mini-Baseplate got 510(k) clearance on January 13, 2012.
  • The Comprehensive Reverse Shoulder – Titanium Glenosphere got 510(k) clearance on August 27, 2013.
  • The Comprehensive® RS Shoulder System got 510(k) clearance on September 28, 2007.

The previous devices were marketed before the May 28, 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act.

Biomet Settles Comprehensive Lawsuit for $350,000

Biomet agreed to settle a lawsuit involving its Comprehensive Reverse Shoulder System for $350,000 in February 2016 according to the Schmidt National Law Group.

The lawsuit was filed in the U.S. District Court for the District of Colorado by a man who was implanted with two Biomet Comprehensive systems. The devices later fractured and the man had to undergo additional surgeries to remove and replace the failed systems.

The plaintiff sued Biomet for product liability in 2014, and the company agreed to settle those allegations roughly two years later in February 2016.

More than 50,000 Americans undergo shoulder replacement surgery each year to relieve joint pain. There are several types of shoulder replacement surgery, including conventional and reverse shoulder replacement.

Reverse shoulder replacement is performed in patients who have completely torn rotator cuffs or previously failed replacement surgeries. Reverse implants rely on different muscles to move the arm than traditional implants and can help restore some motion to these patients who have lost mobility in their shoulders due to severe pain.

Merely three years after Biomet’s Comprehensive reverse shoulder hit the market, the company initiated a recall of certain components of the system.

In a September 2010 Urgent Medical Device Recall Notice, Biomet said it was pulling at least 45 humeral tray and 45 locking ring components in distribution in eight states. The company said it initiated the recall after receiving complaints that the device was fracturing after being implanted.

The FDA posted the recall in December 2010 and labeled it 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 the agency’s website.

The humeral tray and locking ring components were recalled from at least eight states in the U.S., including New York, Virginia, Maryland, Alabama, Colorado, South Dakota, Texas and Oklahoma.

 

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