Complaints About the Stryker Rejuvenate Hip Implant Even Before the Recall

Unfortunately, a growing number of American baby boomers are facing the need at some time in their life of a hip replacement.

Whether due to osteoarthritis in the hip joint, rheumatoid arthritis, osteonecrosis or a death of the bone in joints, injury of a hip joint, or a bone tumor, upward of 500,000 hips are replaced annually in the U.S. In 2010, metal hips accounted for just over one-quarter of all hip implants, and that number is down from 2008 when about 40 percent of all hip implants were metal-on-metal or MoM.

When the Stryker Corporation voluntarily recalled the Stryker Rejuvenate and ABG II modular-neck hip stem systems on July 4th of this year, the adverse reports had been rolling in, suggesting something was failing with this new generation of modular hips – which were supposed to be an improvement over metal-on-metal hips.

Currently there are more than 60 adverse event reports filed with the FDA’s MAUDE incident reporting system and the Rejuvenate device has only been on the market since 2009.

What are patients saying?

We looked into the FDA’s database for research on the Stryker Rejuvenate Modular hip for 2012 and found an additional 33 reports since May 22, 2012. These included reports of pseudotumors, increased metal ion levels in the blood, corrosion, metallosis, metal reaction to implant debris, loosening and pain.

While these reports are made by the manufacturer, hospital or doctor, they are fairly clinical but make no mistake – each represents a devastating, life-altering injury to a patient.

Here’s what they say:

*January 10, 2012 – Rejuvenate Size 7 Stem – “It was reported that, “The PT (patient) was revised due to corrosion of neck, stem and taper”

* January 18, 2012 – “The PT presented with pain. The stem was loose. The doctor proceeded to DePuy Solution stem and head. The PT’s first surgery was performed elsewhere. No notes. Chart Stickers Etc. No lot codes. No other info per hospital protocol”

*April 12, 2012 – Rejuvenate Strght Prfit MTZF Modular system – “…PT was complaining of severe pain in her hip. When the surgeon opened up her hip joint, he discovered a large pseudo tumor and extensive muscle damage. When the modular was removed, there was extensive corrosion noted with black debris noted on the neck. The stem was then completely removed and the PT was revised with a restoration modular cone conical?”

*April 17, 2012 Unknown Rejuvenate Modular Neck – “The team has received verbal communication from Dr. that he has 10 PTS that have a potential metal sensitivity to the Rejuvenate modular Stem/Neck. These PTS have not yet been revised. As the team has more info they will continue to provide it.”

*May 2, 2012 Rejuvenate Strght Prfit TMZF Mod Stem Size 8 – “It was reported PT has had pain over the last few months and was taken to the operating room for exploration. A large trochanteric bursa was found and excised. Upon deeper exploration, a large mass of tissue was taken in and around the joint.”

Remember, these reports often come from the manufacturer which some latitude to decide whether the patient injures are related to its medical device. Many of these narratives say something like:

“An evaluation of the device cannot be performed as the device remain implanted in the patient and was not returned to the manufacturer.”

As patients become more aware that their medical device is failing they begin to ask tough questions. Here’s one from a patient:

*June 14, 2012 Unknown Rejuvenate – “The patient can not walk. She is in pain and has high levels of COCR [cobalt chromium] in her blood stream. The patient’s daughter would like to know how Stryker can help her mother. She will not provide any further information until she is told how it will help them.”

That is a great question.

Stryker has been reluctant to offer help and has failed to take a leadership role to establish the most efficient evaluation of patients. Instead, Stryker is misleading patients into believing they don’t have to see a doctor unless they have symptoms of pain.

One surgeon we consulted with says as many as 30 percent of his asymptomatic patients have elevated cobalt in their blood and evidence of tissue destruction.

That means they are in the active process of losing soft tissue and muscle around the implant, the degree to which is an important factor in determining their prognosis after revision surgery. Without tissue and muscle, holding a new implant in place becomes increasingly difficult.

Additionally, these are particularly difficult surgeries in that the stem is embedded into the femur.

While Stryker is taking a “wait and see” approach to patients, we strongly urge you to have your blood tested for the presence of metal ions. This is for your benefit in that often patients have no symptoms while these defective devices are wreaking havoc on your body.

Stryker has not done a service to its patients and its follow-up medical advice is suspect, to say the least.