Zimmer Biomet, a major manufacturer of shoulder implants, announced a U.S. recall of its shoulder devices after many complaints of shoulder fractures causing severe pain, permanent loss of shoulder function, infections and other serious injuries.
The FDA announced a Zimmer Biomet Comprehensive Reverse Shoulder Class I recall earlier in February, after finding that the fractured shoulder implants had a risk of severe injury or death.
Zimmer Biomet Shoulder Implant Failure and Recall
The Zimmer Biomet shoulder implant devices are used to repair arm movement in patients with torn rotator cuffs, shoulder arthritis, and folks who had previous failed shoulder joint replacements.
Reverse shoulder replacement is generally performed in patients with large rotator cuff tears who have developed a severe type of shoulder arthritis called “cuff tear arthropathy.”
Unfortunately, routine shoulder replacement is not an option for these patients, because the surgery may lead to pain and limited motion. The reverse total shoulder replacement uses the deltoid muscle, instead of the rotator cuff, to power and position the arm.
Zimmer Biomet “Urgent Medical Device Recall Notice”
Zimmer Biomet sent an Urgent Medical Device Recall Notice to its doctors and hospitals in December 2016.
The recall affects 3,662 Biomet Comprehensive Reverse Shoulder Humeral, encompassing all lots with part number 115340. They were manufactured between August 25, 2008 through September 27, 2011; and were distributed between October 2008 and September 2015.
Quick Faqs: Zimmer Biomet Shoulder Implant Lots
- Manufactured from August 25, 2008 to September 27, 2011
- Distributed from October 2008 to September 2015
- Product Codes: KWS, PAO
- All lots with part number 115340
Third Biomet Shoulder Replacement Recall
This is not the first ride at the recall rodeo for Biomet. Comprehensive Reverse Shoulder products have been recalled twice:
In September 2010, Biomet, Inc. recalled the Comprehensive Reverse Shoulder Humeral Tray with Locking Ring because of complaints that the device was fracturing at the joint between the trunnion and the baseplate.
In April 2011, a Biomet shoulder replacement recall was issued for Custom Comprehensive Reverse Shoulder Humeral Trays. According to the recall notice, some of the Humeral Trays may contain a locking ring that is incorrectly assembled.
Colorado Biomet Comprehensive Reverse Shoulder Lawsuit
Last year, a Biomet shoulder replacement lawsuit resulted in a $350,000 settlement. Alfonse Alarid, from Colorado, underwent two Comprehensive Reverse Shoulder surgeries in 2009 and 2010.
According to Alarid, both Biomet shoulder devices failed at the joint between the trunnion and the baseplate, forcing him to undergo painful revision surgery to remove and replace the implants. Alarid filed his lawsuit in the U.S. District Court, District of Colorado.
Both of the allegedly defective shoulders included components were involved in the 2010 Biomet shoulder replacement recall. (Alfonse A. Alarid v. Biomet, Inc., et al., No. 14-2667)
FDA Fast-tracked the Comprehensive Reverse Shoulder Device
The Comprehensive Reverse Shoulder was approved for sale in 2008, by the FDA’s controversial 510(K) fast-track program, which allows a medical device maker to avoid human clinical trials if they are able to show that a medical device product is “substantially equivalent” to another device that was previously approved by the agency.
Injured? Complain here
Any doctors or patients who experience a problem are requested to make a report to MedWatch, the FDA adverse event reporting program.
Our law firm is investigating and accepting Zimmer Biomet Shoulder Implant failure personal injury and product liability claims from across the country. If you or a loved have been injured by Zimmer Biomet Shoulder Implant failure, including fracture, pain, infections and re-do surgery, please contact our office immediately for your free consultation.
Shezad Malik is an Internal Medicine and Cardiology specialist, a Texas Medical Doctor (retired) and Defective Medical Device and Dangerous Drug Attorney. Dr. Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.