The Stryker Orthopedics PER Letter: Why All Rejuvenate and ABGII Hip Implant Recipients Should be Cautious

If you are the recipient of a Stryker Rejuvenate or ABGII hip implant then perhaps you have experienced problems related to the implant. Like other metal-on-metal hip implants, the Rejuvenate and ABGII have the potential of causing metallosis even though the design calls for a ceramic head rather than a metal one. Stryker issued a recall of the both implants this past July, 2012 after first issuing an Urgent Field Safety Notice to hospitals and physicians in the prior April. This notice cited the potential of fretting and corrosion at the neck juncture as well as the risk of metal ion release.

While there is not the same level of surface area as the all-metal implants, the corrosion which can occur in the Stryker Rejuvenate and Stryker ABGII can nonetheless lead to metallosis. In addition to the neck juncture which can result in corrosion, there are metal trunnions located at either end of the neck which allow the component to snap into the stem on one end and the acetabular cup on the other. Body fluids can become trapped under these trunnions, leading to further corrosion. 

Consolidation of Stryker Rejuvenate Hip Lawsuits Placed in New Jersey

The state of New Jersey is expected to consolidate at least ten StrykerRejuvenate and ABGII hip implant lawsuits before one judge in order to expedite the handling of these cases. Multi-district and multi-county litigation is described by Class Action Litigation website as a procedure utilized by federal and state courts to transfer all pending cases which are very similar in nature before one judge. This procedure allows lawsuits to move in a more expeditious manner through the discovery phase while still allowing the injured party to seek an individual trial and have their settlement adjusted based on the degree of injury. This is unlike class action lawsuits which dictate that all members share equally in the settlement even though it is unlikely that all injuries would be equal. The first ten cases are coming from Florida, Minnesota, New Jersey and Arizona. Hackensack, NJ was chosen as the consolidation point because it is close to Stryker headquarters.

Problems With Rejuvenate and ABGII

The lawsuits followed the recall in July of 2012 for the Rejuvenate and ABGII. The recall was voluntary on the part of Stryker and cited the risk of fretting, corrosion and the release of metal ions as the reason for the recall. Pain, inflammation, necrosis, metallosis and total failure of the hip implant can all result from the fretting and corrosion of the hip implants. These implants were originally marketed as a way for younger clients to be able to continue their levels of activity as they were believed to last from 15-20 years. Stryker’s innovative design offered a variety of necks and stems, allowing physicians to more closely match the implant to the size and activity level of the patient. Even though the Rejuvenate and ABGII are not all-metal (they have a ceramic ball and a plastic cup liner) they have the same potential for the release of metal ions into the body as the all-metal implants. 

Sales Dip for Stryker Following Hip Implant Recalls

Stryker sales have shown a definite dip in the quart since the recall of the Stryker Rejuvenate and ABGII hip implants in July. The hip implant recall came just months after Stryker issued an Urgent Field Safety Notice to hospitals and physicians in April of 2012 citing the potential of fretting and corrosion at the neck juncture as well as the risk of metal ion release. Stryker’s hip implant sales dropped nearly 10 percent while its knee implant sales dropped 4.3 percent.

Why the Dip in Revenues?

A Stryker company official stated the recalls of the Rejuvenate and ABGII had only a “modest impact” on the company’s third quarter drop in sales. While the recalls certainly would have impacted Stryker’s revenues, the overall economy may also have played a part. Joint replacement surgical procedures are considered elective most of the time. Those with insurance may delay the surgery to avoid missing work while those without insurance likely cannot afford the procedure. Stryker’s CFO, Curt Hartman also stepped down after two decades at the helm. He reportedly received a 1.5 million dollar separation package although he will remain as an adviser to Stryker through February, 2013. 

Why Diagnosing Problems in Stryker Rejuvenate Hip Implants is So Difficult

When the Stryker Rejuvenate and ABGII were recalled in July of 2012, citing potential risk of fretting and corrosion at the neck juncture, many of the implants had already been removed during revision surgeries. Unfortunately, since most physicians were unaware of the problems with the implants, the operative reports were unlikely to list this corrosion. In other words, since the doctors hadn’t been told what issues to look for, there were few records stating that corrosion was a factor in the revision surgery. When Stryker originally told hospitals and surgeons (in an Urgent Field Safety Report in April of 2012) that there could be corrosion or fretting and release of metal ions, there was still no mention of that corrosion occurring anywhere except at the neck juncture.

Therefore, the neck juncture would likely have been the only place physicians would have examined when taking out the implant. In the same vein, when implant recipients came to their doctor complaining of pain or other symptoms, the doctor would have ordered x-rays, an MRI and a bone scan. Again, without clear information regarding what to look for, many physicians might have attributed their patient’s complaints to external issues such as the aging process.  The Rejuvenate, unlike former metal-on-metal hip implants, is a four-part device with a ceramic ball and a plastic liner in the cup. Because of these improvements, it was believed there would be no metal parts rubbing against one another causing metal ion shear. 

Stryker Rejuvenate Hip Implant: What is the Real Problem?

Just this past July Stryker Orthopedics issued a voluntary recall of their Rejuvenate and ABGII hip implant systems citing a potential for fretting and corrosion at the metal neck junction. The FDA convened a panel shortly before this recall to discuss the merits of continuing to use metal-on-metal hip implants due to the high number of complications suffered from recipients. The design of the Rejuvenate was believed to overcome most issues associated with the all-metal hip implants as it allowed surgeons to custom-fit the stems and necks of the implants to the size and relative activity level of the patient.

The Rejuvenate Design

The Stryker Rejuvenate consists of a ceramic ball which fits into a plastic-lined socket. Because there was no metal-on-metal ball and socket it was believed there were no metal surfaces which could potentially rub against one another, causing metal ion debris to enter the surrounding tissue or bloodstream. The Rejuvenate is essentially a two-piece system in that the properly sized metal stem and neck connect to one another then connect to the ceramic ball. The neck is made of chromium and cobalt, just like the all-metal implants and the stem is coated with titanium. Even so, by using a ceramic ball and a plastic-lined socket, it was believed there would be no issues regarding metal ion debris.