Zimmer Biomet Bone Cement Lawsuit Filed Over Failed Knee Replacement

Patient discovered the cobalt bone cement had been recalled due to bonding defects, but only after it failed during her own knee replacement surgery.

A Louisiana woman has filed a product liability lawsuit against Zimmer Biomet, alleging that recalled Cobalt Bone Cement used during her knee replacement surgery failed to properly bond, resulting in permanent injuries and the need for additional revision procedures.

The complaint (PDF) was brought by Beverly Williams in the U.S. District Court for the Western District of North Carolina on July 1, naming Zimmer Biomet and its subsidiaries as defendants.

Zimmer Biomet Cobalt HV (High Viscosity) Bone Cement with Gentamicin is commonly used during orthopedic joint replacement procedures, including total knee and hip arthroplasty. The cement is designed to anchor metal implants to the surrounding bone, creating a solid, stable interface that ensures the prosthetic functions properly within the body. To effectively form a durable bond between the bone and prostheses, the bone cement must maintain consistent viscosity and sterility.

Cobalt Bone Cement Recall

In June 2017, Zimmer Biomet issued a Class II medical device recall for the Cobalt HV Bone Cement due to a packaging defect. The FDA recall notice indicated that a flaw in the Tyvek pouch used to seal the sterile product could result in a compromised seal. However, this came after the bone cement had already been used in medical procedures.

Officials warned that the compromised seal could lead to contamination or chemical degradation, which might prevent the cement from curing correctly or adhering to implants, posing a serious risk of loosening and surgical failure.

However, despite the recall, Williams’ lawsuit alleges that the defective cement remained in circulation and was used in a knee replacement procedure more than a year later.

Outlined in the complaint, Williams states she underwent a left knee replacement in 2014, followed by a revision surgery in November 2018. During that second procedure, surgeons used Biomet Cobalt Bone Cement to anchor a new implant. However, Williams later learned that the cement failed to bond the hardware to her bone.

In July 2020, she underwent a third knee surgery. During the operation, her surgeon observed that the cement mantle remained intact but had completely failed to adhere to the underside of the tibial baseplate, a sign that the bonding function never occurred. Williams claims the cement was used as directed, with no modifications or misuse by her or her healthcare providers. 

According to the lawsuit, Biomet failed to design, formulate, and adequately test the bone cement to ensure it was in a reasonably safe and merchantable condition for its intended medical use, duties that manufacturers are legally obligated to uphold when placing medical devices into the stream of commerce.

Williams presents claims of negligence, manufacturing and design defect, and breach of implied warranty of merchantability, indicating she suffered severe, painful, permanent injuries and disfigurement as a result of the defective bone cement.

Zimmer Biomet Lawsuits

The issue Williams describes in her complaint is not the first time that a Zimmer Biomet device has been accused of failing after implantation in a patient.

Already this year, a Biomet Phoenix Ankle Nail system lawsuit claimed the manufacturer knew of risks from its system, but failed to warn doctors or patients, exposing them to serious and avoidable health complications.

Another lawsuit filed that same month also indicated that a Zimmer Biomet Vanguard knee replacement failed inside a patient’s body years after the original recall was issued.

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