TAMPA, Fla. – An Idaho man claims the maker and distributor of a shoulder prosthesis should have known – and had a duty to warn consumers such as himself – about the device’s hazards, in a federal lawsuit.
Plaintiff Kurt Wortmann filed his lawsuit in U.S. District Court for the Middle District of Florida. The named defendants are FH Orthopedics Inc., or FH Ortho, in Pennsylvania and OrthoSource Inc. in Florida.
In his 22-page complaint, Wortmann takes aim at FH Ortho’s ARROW Universal Shoulder Prosthesis.
“The injuries from the dangerous and defective ARROW Universal Shoulder Prosthesis (reverse) that injured Mr. Wortman caused, and will continue to cause, pain and suffering in the form of limited shoulder mobility, limited ability to physically engage with him [sic] family and in beloved activities, and economic losses in the form of medical expenses in an amount to be determined by a jury,” his filing states.
Wortmann, now an Idaho resident, was implanted with the prosthesis – designed and manufactured by FH Ortho, and distributed, sold, marketed, and serviced by OrthoSource – in July 2019 at Sarasota Memorial Hospital in Florida.
Introduced in 2006, the ARROW prosthesis was one of the first universal systems for hemiarthroplasty, total shoulder arthroplasty, and reverse shoulder arthroplasty.
The ARROW device is used to replace both the ball, or humeral head, and socket, or glenoid, of the shoulder with implants designed to mimic the joint’s natural shape and function.
In a reverse total shoulder replacement, the natural “ball and socket” anatomy of the shoulder is swapped. A metal ball is attached to the shoulder socket, and a cup is placed on the upper arm bone. This structure relies on the deltoid muscles to move the arm.
A reverse total shoulder replacement surgery is often intended for individuals with significant damage to their rotator cuffs.
According to his complaint, Wortmann had suffered from shoulder pain for much of his adult life. He experienced severe damage to the rotator cuff in his left shoulder from injuries sustained from work-related incidents and from sports injuries.
“These injuries left Mr. Wortmann with chronic shoulder pain which inhibited his sleep, his range of motion, and his ability to lead a normal life,” his filing states.
After undergoing surgery in 2003, Wortmann was still experiencing pain in his left shoulder. In 2017, his doctor diagnosed him with a massive recurrent rotator cuff tear, and said the damage was so severe that it warranted a total shoulder replacement.
On July 9, 2019, he was implanted with FH Ortho’s ARROW device.
“The implant initially appeared to work well,” his complaint states. “Mr. Wortmann experienced no immediate infections or complications from the surgery and was discharged from SMH after a few days of post-op care.”
Nearly five years later, Wortmann, now living in Idaho, claims he raised his arm to change his shirt and heard a “popping” sound.
After, he claims he started noticing a frequent and audible “clunking” sound coming from his left shoulder with short bursts of severe pain.
In July 2024, his surgeon advised him he needed revision surgery of his failed shoulder implant. He had his implant removed later that month at St. Luke’s Hospital in Boise, Idaho.
“During surgery, Dr. Clark found, among other things, ‘Metallosis within capsule,’ and ‘Glenosphere dissociated with a broken central screw,’” the filing states. “Dr. Clark also noted that, ‘There was extensive scar tissue and deltopectoral interval was not easily identified… Shoulder was dislocated and tray and polyethylene component were removed. Glenosphere was then visualized and was loose.’”
Additionally, Wortmann claims his revision surgery was complicated by a screw breaking with attempted removal.
“Friction between the glenosphere and a defectively worn polyethylene insert, and between the glenoid base plate and the related glenosphere and screws, results in metal-on-metal wear, creating metallic debris,” the complaint states.
“This process results in damage to the components, the release of additional toxic heavy metal particles into the body, component failure, and the need for surgery to replace the failed components.”
Wortmann’s lawsuit claims the heavy metal toxicity can lead to high metal levels in the blood and soft tissue, metallosis, infection, loosening, tissue death, bone death, neurological issues, cognitive decline, among other problems.
“If the components are not removed early enough, the effects can be irreversible,” the suit states.
Wortmann argues the ARROW device’s polyethylene was defectively manufactured, causing it to degenerate prematurely – resulting in metal-on-metal contact, friction, and metal particle and ion release from a metal-on-metal articulating surface.
His complaint notes that an initial report detailing the product’s failure and his surgery was received by the FDA in their Manufacturer and User Facility Device Experience, or MAUDE, database in September 2025.
A search of the MAUDE database reveals that the FDA received another report about the device in December 2024.
“At all relevant times and before the implantation of the ARROW device in Kurt Wortmann, FH Ortho, knew or reasonably should have known that the device they had designed, marketed, advertised, promoted, manufactured, sold, and/or distributed was defective and harmful to consumers, including, but not limited to, the propensity for the device to cause some patients to develop adverse reactions to metal debris generated by normal use of the device,” the complaint states.
“Not to mention, the dissociation of the glenosphere and the devices’ defective fractured screw causing a prolonged and complicated revision surgery.”
Wortmann seeks damages, attorney fees and costs. He is represented by mctlaw in Sarasota.
