Former Nurse Left Disabled After Exactech Shoulder Implant Failure

Naomi Jones was working as a home health nurse and raising her children when a shoulder injury eventually led her to undergo a total reverse shoulder replacement several years ago.

She hoped the surgery would restore stability to a shoulder that had repeatedly dislocated after an injury. Instead, within a few years, Jones says her Exactech Equinoxe shoulder implant had broken apart inside her body.

Today, the former nurse has almost no use of her dominant right arm. Her doctors were unable to give her another shoulder replacement because of extensive bone loss.

“I can’t even raise my right hand, and I’m right-handed by the way,” Jones, who is using an alias to protect her privacy, told Drugwatch. “I can raise my hand almost to my mouth, but not all the way.”

Jones shared her experience with Drugwatch because she wants other people with joint replacements to research the devices and know they aren’t alone.

Jones first injured her shoulder during a fall because of a seizure several years before her surgery. Her shoulder became increasingly unstable over time, eventually leading to the procedure.

She received an Exactech Equinoxe total reverse shoulder replacement. For about a year, Jones said everything seemed fine.

Then the problems began.

Her shoulder started popping out of place again, forcing her to make repeated trips to the emergency room. Over time, the pain became so severe that she eventually stopped working.

By the time she sought further evaluation, Jones said doctors told her the implant was completely broken and needed to be removed.

“It’s twisted. And there were fractured screws. And I could actually touch a part of my skin right there on my shoulder, and you could feel the screw point with your finger,” she said.

The pain was relentless.

“I was in agony every day. It was horrible,” Jones said.

Jones underwent surgery to remove most of the failed implant, but another shoulder replacement wasn’t an option.

Jones said her surgeon told her there was too much bone loss and damage to secure a new implant.

“He said, ‘I can’t [perform surgery], there’s nothing to attach it to,’” she recalled.

Without a functioning shoulder joint, Jones said the weight of her arm pulls against the remaining muscles, tissue and nerves, causing daily pain.

The consequences have changed virtually every part of her life. Jones, who once worked in the physically demanding field of home health nursing, is now disabled.

“I can’t raise my right arm at all,” she said. “I mean, I can bend from the elbow, but other than that, you know, I can’t raise my right arm at all. I have no use of it at all.”

Jones initially didn’t know why her shoulder replacement had failed so severely. She even wondered whether she had somehow caused it.

“I questioned that for like months,” she said.

Eventually, Jones began combing through her medical records and researching her implant. She searched for FDA information and tracked down model and serial numbers for the individual components.

But she isn’t the only patient to experience complications from Exactech joint replacements. Her research eventually led her to information about problems involving Exactech implants.

The U.S. Food and Drug Administration has warned patients and health care providers in recent years about potential health risks involving certain Exactech Equinoxe shoulder replacement devices.

“I knew something was not right,” Jones said. “I didn’t do anything to fracture screws inside my body. You know, I didn’t do anything for that to happen.”

According to the FDA, some Exactech devices were packaged in defective bags that lacked an oxygen-barrier layer designed to protect plastic components from oxidation. Oxidation can degrade plastic over time and increase the risk of device wear or failure.

Exactech has also recalled tens of thousands of hip, knee and ankle replacement devices because of defective packaging. Patients like Jones have filed Exactech lawsuits alleging some devices failed prematurely and caused complications, including bone loss and the need for revision surgery.

“You have to literally know what you’re looking for in order to find stuff,” Jones said. “So that’s why I got on my medical records, and I had to figure out serial numbers, model numbers, you know, all of that.”

Jones has spent countless hours researching Exactech recalls, medical devices and litigation since losing the use of her arm. But she doesn’t want that knowledge to benefit only her.

“It’s in God’s plan for me to know all this stuff for a reason. It’s to help somebody,” she said.

Her message to other people with joint replacements is to learn as much as possible about the devices implanted in their bodies.

“Do your research,” Jones said.

She especially thinks about patients dealing with failed hip, knee and ankle replacements and the families who have watched loved ones suffer.

“My heart just really goes out to those people and their families,” Jones said. “I just hope something can come out of this, that they can take away from this and learn.”