Medical manufacturing company Zimmer Biomet is facing major legal repercussions for problems with their Biomet Reverse Shoulder replacement.

According to injury reports, the Biomet Reverse Shoulder replacement is linked to a high rate of fractures, along with infection in the shoulder area, permanent shoulder function loss, and death.

Each year, approximately 50,000 patients in the United States undergo shoulder replacement surgery per year using different products like the Biomet Reverse Shoulder replacement.

These devices are meant to relieve joint pain and restore shoulder function, with reverse shoulder replacement being a suitable option for patients who have experienced failed replacement procedures and who have severe rotator cuff damage.

The Biomet Comprehensive Reverse Shoulder Replacement was approved by the FDA in 2007, and was meant to be the “next generation reverse shoulder prosthesis.” However, Biomet Zimmer announced a Class I recall several years later due to high rates of fracture.

The FDA released a public warning in February 2017, advising patients and physicians that Zimmer Biomet had issued a recall of its Comprehensive Reverse Shoulder replacement implant. The company had recalled its Biomet Reverse Shoulder replacements due to the fracture rate being higher than what is stated on the product’s warning label.

The FDA had categorized the recall as Class I, which is only given to medical devices linked to serious injuries or death. As mentioned in the recall, the Zimmer Biomet Comprehensive Reverse Shoulder replacements were primarily affected and have been linked to incidents of dangerous fractures.

Reverse shoulder replacements attach on the socket side of joint, which is reverse of where the joint is naturally. Patients who receive Biomet Reverse Shoulder Replacement often have cuff tear arthropathy prior to the shoulder replacement, or have had their tendons so badly damaged that traditional shoulder replacements would not work.

Overview of Biomet Reverse Shoulder Replacement Complications

The company had issued the recall after a  study published in the Journal of Shoulder and Elbow Surgery reported that patients who suffered fractures after shoulder replacement were six times more likely to die within 30 days compared to other patients.

Causes of death associated with shoulder replacement surgery include cardiac, pulmonary and abdominal complications. Due to the severity of these complications, Zimmer issued a recall of its Biomet Reverse Shoulder replacements.

The company had also issued a Certificate of Acknowledgment to healthcare providers on Dec. 20, 2016, asking the facilities to quarantine and remove any remaining stock of Biomet Comprehensive Reverse Shoulder devices.

The recall affects Biomet Reverse Shoulder replacements distributed between October 2008 and September 2015 ─ around 3,662 units. During this time, the company reportedly provided no new follow-up care instructions for patients except for the existing protocols already provided.

Patients who have experienced fractures from Biomet Reverse Shoulder Replacements may be able to file legal action against the manufacturing company. Potential claimants should contact a medical device lawyer to determine eligibility for a Biomet Reverse Shoulder Replacement lawsuit.