The Stryker Product Experience Report Letter: What every Rejuvenate and ABGII Hip Implant Recipients Should Know
Tuesday, January 1, 2013
Perhaps you are one of the many recipients of a Stryker Rejuvenate or ABGII hip implant who have experienced problems with the implant and are unsure what to do. The Stryker Rejuvenate
and Stryker ABGII were both recalled this past July, 2012 - although both had been on the market only 3-4 years, with the Rejuvenate gaining FDA approval in June, 2008 and the ABGII in November of 2009. The Rejuvenate and ABGII systems were considered extremely advanced because rather than employing a one-piece femoral stem and neck, these newer designs implemented a two-piece modular neck and stem. This design allowed surgeons to choose the component combination which best fit each patient’s unique anatomy.
While both models were marketed as being much safer than other metal-on-metal hip implants on the market due to the use of a ceramic head, it was later found that there was a significant risk of corrosion at the neck juncture and the area beneath the metal trunnions
. When any level of corrosion occurs in a hip implant, tiny metal ions can be released and may either become lodged in the tissues surrounding the implant or can enter into the bloodstream of the recipient. Pockets of swelling—known as pseudo-tumors—resulting from the metal contamination in the body can also occur in some patients. When the metal ion levels build in, they can lead to a variety of serious medical problems for the recipient.
Medical Issues from Metal Ions
When lodged in the tissues in the hip area, inflammation and pain are common. The tissues can begin to deteriorate, eventually dying completely. Bone loss can occur and in some patients, total failure of the implant, requiring the patient to undergo revision surgery. Once the cobalt and chromium ions enter the bloodstream, neurological, cardiovascular, renal and thyroid issues can occur as well as deterioration of vision and hearing, balance issues, memory loss and even disruption of DNA. The FDA has received over 60 reports of Stryker hip problems
related to the implantation of a Rejuvenate or ABGII, with many devices failing within a year and a half of initial implantation.
Receipt of a Stryker PER Letter
If you are a recipient of the Stryker Rejuvenate or Stryker ABGII hip implant who has had trouble with the implant, perhaps you or your physician, or your treatment facility notified Stryker of your implant problems. You may have received—or will receive—a letter from Stryker in response to this notification, known as a product experience report
letter or PER Letter. Should you receive such a letter from Stryker it could, on its face, sound fairly inconsequential, and you might feel there is little harm in releasing your medical records to Stryker. It is important that you understand other facts regarding a PER letter. First, once Stryker is aware you have experienced a specific issue with one of their implants they can now label you a potential claimant.
Problems With the PER Letter
There is no third party oversight involved in the PER letter, meaning Stryker could reply with nothing more than a “best assessment” of their implant’s performance. Since lawsuits have already been instigated against Stryker regarding the Rejuvenate and ABGII hip implant models, your PER response and medical records could potentially be used in a legal capacity in the future. Once Stryker has full access to your medical records, they have gained a potentially important advantage over you in the event a lawsuit ensues. There is yet another issue regarding the PER letter Stryker recipients could receive.
Former DePuy CEO Now Working for Stryker
According to massdevice.com, former DePuy Orthopaedics CEO, David Floyd—who left DePuy amidst a recall of the ASR hip implant—first went to OrthoWorkx, an initiative aimed at boosting the orthopedics sector. Following that position, the Houston Chronicle reported that just last month Floyd accepted the position as head of Stryker’s orthopedics unit. The lawsuits following the DePuy ASR recall have been very costly, and Stryker is facing at least 10 Rejuvenate lawsuits with more expected to follow. Following the DePuy ASR recall, a letter known as the “Broadspire” letter was sent out to recipients of the implant, stating that patients meeting specific criteria could be eligible to have certain medical costs related to the implant covered.
Could Stryker be Considering a Letter Similar to the Broadspire?
DePuy required the patient’s medical records in order to determine whether revision surgery was absolutely related to the ASR recall rather than another cause. In other words, the company could attempt to blame the implant failure on any other condition they found in the patient’s health records, meaning the recipient had signed away their rights in return for nothing. The Stryker PER is a quality control mechanism utilized by the company since before the Rejuvenate and ABGII recalls. But while Stryker is not
offering to cover medical expenses in their PER letter (as the Broadspire Letter does), that could certainly occur down the road. Presently it appears that Stryker is merely attempting to obtain patient information which could conceivably be used to the implant recipient’s detriment in the event of a future lawsuit.
Many DePuy patients who trustingly waived their legal rights by signing the Broadspire letter paperwork, found their prior health issues being used against them. Perhaps the recipient was overweight, over-active, or had suffered an injury to their hip in the past—suddenly the responsibility for the failure of a (recalled) implant was shifted to the patient. In some cases the surgeon was blamed, citing improper implantation, and rarely were the patient’s medical records used as a means of helping them deal with the trauma and expense of a failed hip implant.
Consider Carefully Prior to Signing a Stryker PER “Authorization for Disclosure”
The Stryker PER letter is not
asking patients to waive their rights to a future claim, is not
offering revision surgery for qualified patients and is not
seeking to obtain the removed implant. There are
, however, definite disadvantages to the Rejuvenate or ABGII recipient who allows Stryker access to their medical records. Considering that David Floyd spearheaded the Broadspire campaign during his time as CEO of DePuy, it is not inconceivable that such a campaign could be forthcoming in the case of the Rejuvenate and ABGII recalled implants.
Therefore, it is certainly worth a second thought before an implant recipient signs a PER letter “Authorization to Use or Disclose Health Information”. Remember that a Rejuvenate revision surgery is potentially much more serious than revisions for other types of hip implants. The stem of the Rejuvenate is implanted much more deeply into the femur bone, therefore when it is removed it must literally be dug out; this greatly increases the risk of the femur shattering or fracturing during the surgery. The recovery time for a Rejuvenate or ABGII revision is also considerably longer than for other revision surgeries. It is very important that you not inadvertently jeopardize your entitlement to compensation as revision surgery can accumulate extremely large amounts of medical expenses.