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. 

In some cases, recipients of the Rejuvenate or ABGII could receive a letter from Stryker in response to an issue with the implant reported to Stryker by the patient or the patient’s physician, or by the patient’s treatment facility. This letter, which states it will initiate a Product Experience Report—or PER—generally appears fairly mild, thanking the patient or doctor for submitting their Stryker hip implant concerns. The letter also likely indicates that a PER will be put together for the patient and that the patient must only sign the included “Authorization to Use or Disclose Health Information”, allowing Stryker access to their medical records in order to fully investigate the issue. If you are in receipt of such a letter from Stryker, be very cautious regarding signing the form which gives Stryker access to your medical records.

DePuy’s Broadspire Letter

When DePuy’s ASR implant was recalled and lawsuits began being filed, the company contracted with Broadspire to issue a letter to implant recipients which essentially offered to pay revision surgery costs to all those who met the criteria. In return, the patient essentially signed away their right to file suit against DePuy down the line, agreed to allow DePuy access to their medical records, and agreed to give DePuyany implant removed during revision surgery. Many implant recipients gratefully signed the letter, glad to have their revision surgery and related medical expenses paid for. Unfortunately, it turned out to be much less straightforward than promised.

Many implant recipients were painted unfavorably based on their medical records. Company officials were able to point to a myriad of reasons—other than the actual implant—which were responsible for the health problems being experienced. Perhaps the patient was overweight, had diabetes, was very active or had suffered some sort of injury in the past. The most innocent health issue was used to deny deserving patients both their day in court as well as medical expenses related to the implant.

How Does the Broadspire Letter Relate to Stryker’s PER Letter?

Now Stryker’s PER has been a quality control mechanism utilized since before its Rejuvenate and ABGII recalls. But while the PER Letter is not offering to pay for revision surgery or implant-related costs at this point, is not yet asking patients to waive their rights to future recovery and is not requesting that implants which are removed during revision surgery be turned over to them (as the Broadspire Letter does), there are nonetheless potential negative consequences associated with allowing Stryker access to your medical records. Should you allow Stryker to access your medical records, they may first identify you as a potential claimant. They may then use your medical records to lay the blame of your health issues on anything other than their recalled hip implant.

Health Risks of Metallosis

When corrosion of the Rejuvenate or ABGII occurs in recipients of the implant, microscopic ions of cobalt and chromium are released into the patient’s body. Should they become lodged in surrounding tissues, the patient may experience serious inflammation, tissue necrosis and bone loss. Chronic pain is likely, varying from moderate to severe. The hip implant can loosen, leading to total failure and the necessity of revision surgery.  Should the toxic metals enter the bloodstream, they can begin to steadily build up as the corrosion continues. Although each person will respond differently to levels of cobalt and chromium in their body, almost any amount is too much.

Cardiovascular issues, neurological problems, kidney problems and thyroid issues are all possible results from the buildup of cobalt and chromium. Further, vision and hearing loss, gastrointestinal disorders, skin problems, pseudo-tumors, balance issues and loss of memory can also occur as the levels of cobalt and chromium continue to accumulate. Once the implant is removed from the body it could take a considerable amount of time for all the metals to be flushed from the body, and, in some cases, the effects are not reversible. The FDA has received over 60 reports of adverse effects from the Stryker Rejuvenate and Stryker ABGII and many of the implants failed within a year and a half.

A further issue associated with the PER letter from Stryker relates to the fact that the former CEO of DePuy—who was in charge during the aftermath of the ASR recall—is now working for Stryker. David Floyd left DePuy following the ASR recall to go to Ortho Workx. According to the Houston Chronicle, only last month Floyd left Ortho Workx to be head of Stryker’s orthopedic unit. It is not hard to imagine, therefore, that the mild PER letter could eventually lead to a letter similar to the Broadspire letter being sent to recipients of the Stryker Rejuvenate and Stryker ABGII. Many people trusted DePuy to take care of their medical expenses related to the implant based on the Broadspire letter when in fact the released medical records were later used to deny those expenses.

Should You Receive a Stryker PER Letter, Exercise Caution?

It is rarely a good idea to release your medical records to a company who could potentially use those records against you in the future. You also don’t want to threaten your right to a future lawsuit should your recalled Stryker hip implant fail, leaving you to deal with exorbitant medical expenses related to a revision surgery. Revision surgery for the Rejuvenate and ABGII are considered to be much riskier than for other metal-on-metal hip implants because the stem of Stryker’s implants is buried deeply within the femur.

When removed, the bones can shatter or fracture, leading to further surgical procedures and, in some cases, permanent disability. If you have received (or receive in the future) a PER letter from Stryker, consider your options very carefully and use your best judgment in the determination of whether or not you want to allow Stryker access to your medical records. The preservation of a potential claim against Stryker could be at stake.

Stryker Risks and Symptoms