How is Johnny Bench Doing with the Latest Improved Stryker Hip Replacement Device?
On March 10, 2010, the Stryker Orthopaedics Division announced the release of a new hip replacement, the ADM X3 Mobile Bearing Acetabular System. Calling it the “next-generation of technology” in hip replacements, the company announced that Hall of Famer, Johnny Bench, would become the first patient in the world to receive the device. What is missing from that press release and all associated “speaking tour” videos cut by Mr. Bench is what stem was implanted in Mr. Bench.
Stryker was aggressively trying to distance itself from the complications associated with metal-on-metal hip implants that have been generating news headlines, thousands of injured patients around the globe, and defective product lawsuits.
A deeper look into the company’s website shows this latest generation is made of precisely engineered polyethylene, “designed to help minimize the risk of wear and consequently help prolong the life of the implant.” And the X3 mobile bearing hip system offering a large head, thought to be more stable than a smaller diameter head.
Good luck on the newest generation of hip replacements if the past is any indication. And, perhaps the silence is because Mr. Bench was the unfortunate recipient of either a now recalled Rejuvenate or ABG II modular stem.
Bench became a paid spokesman for Stryker after he received his first hip implant in 2004. The former professional baseball catcher, who played in the Major Leagues for the Cincinnati Reds from 1967 to 1983, blamed the 400,000 squats he did during his 17-year career for his arthritic and deteriorating left hip.
Bench received a Stryker ceramic hip that year. But by 2005, complaints began to surface about the poorly-fitting and squeaking implant which wore unevenly causing pain, bone fractures, and difficulty walking in some patients.
The U.S. Food and Drug Administration (FDA) warned Stryker about the complaints in a six-page letter. Bench had experienced some squeaking in his left hip but was quoted as saying, “I don’t care if it plays ‘Dixie’”.
The FDA inspected the Stryker manufacturing plants in Cork, Ireland and in Mahwah, New Jersey and found quality control problems at different stages of manufacturing including the discovery of staph bacteria in New Jersey. The FDA then sent a warning letter to Stryker at its Kalamazoo, Michigan headquarters to president and CEO Steven MacMillan dated November 2007, saying it could seize products if the problems were not corrected.
Stryker recalled two products in the Trident line including the two hip replacement cups, the Trident Acetabular PSL Cup, and the Trident Hemispherical Cups made in Cork, Ireland.
On July 6, 2012, the company recalled the Stryker Rejuvenate and ABG II Modular-Neck Stems due to 60 reports of metal toxicity that led to an early revision or removal of the hip. The surgeon who implanted Mr. Bench with the new ADM bearing surface in 2010 is known to have been a user of the Rejuvenate and ABG II stems.
The Stryker Rejuvenate and ABG II had metal neck components of chromium and cobalt and a stem coated with titanium that led to complications including metallic debris in the bloodstream even without a metal-on-metal junction. Since they do not involve a metal ball and socket, they were not considered metal-on-metal hip replacement devices. But a revision of a stem component, which is placed deep inside the patient’s femur, can be a complicated and difficult surgery.
The Rejuvenate was approved by the FDA in June 2008, with the ABG II was approved in November 2009. Both systems received 510(k) notification approval as Stryker said they were similar enough to other devices already on the market.
That meant the company got a pass on providing clinical studies to prove safety and efficacy. That’s the problem.
The newer Stryker devices are modeled on systems that were already found to be defective and resulted in adverse events such as neck fractures, bone fractures and dead tissue response.
So far there has been no press release from Stryker telling us how Johnny Bench is doing with his right hip replaced with the latest and greatest version of a hip device that may or may not have been based on the design of the defective models preceding it. How embarrassing would it be for Stryker if Mr. Bench in fact had been implanted with defective and recalled Stryker products in both hips?
Word of caution – never volunteer to become the first person to receive a newly issued medical device that is permanently implanted – especially if there were no safety inspections required under the fast-track 510(k) FDA approval process.
Don’t hold your breath for an updated press release.