Lawsuit against Zimmer Biomet alleges implant defect

(photo supplied)

A North Vernon man is suing Zimmer Biomet in Kosciusko Circuit Court for damages after a shoulder surgery that he says caused him pain and other problems, and he is seeking a trial by jury.

Plaintiff Andrew L. Elder is seeking damages and punitive damages from Zimmer Inc. doing business as Zimmer Biomet, according to court documents filed Wednesday.

On or about Oct. 28, 2013, Elder underwent a right total shoulder replacement surgery at Columbus Regional Hospital. The procedure was performed by Dr. Larry Olsen, who implanted Elder’s right shoulder with a Zimmer Trabecular Metal Shoulder System, according to court records.

Following his initial shoulder surgery, Elder experienced pain, loss of range of motion and loosening of the components.

On or about Nov. 16, 2017, documents state, upon recommendation by his doctor, Elder underwent a revision surgery of his right shoulder at the Orthoindy Hospital, performed by Dr. Jeffery J. Soldatis. Following that surgery, Elder suffered and continues to suffer damages, including, but not limited to, disfigurement, pain, suffering, mental anguish, lost earning capacity and medical expenses, the lawsuit contends.

Zimmer sold the Zimmer Trabecular Metal Total Shoulder System to Elder, or to his physician and/or health care provider, on his behalf. The prosthesis reached Elder without substantial change from the time it left Zimmer’s possession and control, and the shoulder system was cleared by the United States Food & Drug Administration. The lawsuit states that Zimmer, by its actions or inactions, caused Elder’s injuries.

Several pages of the lawsuit state that the components of the shoulder implant may have contained a manufacturing defect; the components may have been deviated; and the system was “unreasonably dangerous for its intended purpose because it had a high propensity to become loose” and “had a high propensity for poor bone ingrowth and/or fixation.” It also states the shoulder system was marketed in such a way as to mislead consumers regarding its safety and efficacy and was “inadequately tested.”

Elder is seeking damages on six counts for past and future physical pain, mental suffering, physical impairment, physical disfigurement, reasonable and necessary medical bills, loss of earnings/earning capacity; attorneys’ fees; and court costs. He also seeks punitive damages.

The lawsuit contends that the acts, omissions or both of the defendants that constituted gross negligence include one or more of the following: designing, manufacturing and marketing the shoulder system as defective when it had a high propensity of poor bone ingrowth and/or fixation … (and) when it had high propensity of premature loosening and early implant failure; failing to warn consumers in general and Elder or his physician that the system could become loose; placing the system into the commerce stream though it hadn’t been adequately tested; and failing to properly test the system before marketing it as safe for implantation in the human body.

Attorneys for the plaintiff are Monica C. Vaughan, Houston, Texas, and Michael L. Valentine, Warsaw.