Recently published literature in the Journal of Bone and Joint Surgery draws the conclusion that the short-term, high rate of corrosion-related revision with Rejuvenate modular neck implants is “striking.”
The study out of Houston, Texas is yet another in the mounting swell of unflattering literature condemning this recalled device. To date, several articles have been published each citing revision rates at less than four years as high as 40%. In the world of hip implants that revision rate is staggering or to use the authors’ term, “alarmingly high.” Choose whatever adjective you will to describe this disaster but the bottom line is this device will go down in the orthopedic device industry as the worst mass produced and marketed device in the history of implants. Several doctors I have spoken with are convinced the revision rate may exceed 80% with some offering the opinion that every single one of them will have to be removed.
To put these reported failure rates in perspective, the newly revised NICE Guidelines for implant survivability suggest that any failure rate that exceeds one half of one percent at ten years of implantation is excessive. That works out to a 5% failure rate at TEN years. Reported literature of revision rates at less than 4 years exceeding 20, 30 and 40% means that this is a catastrophe of enormous proportions for Stryker. When the dust finally settles, the Rejuvenate and ABG II failures will make the recently settled DePuy ASR case look tame in comparison.
What’s more telling is the fact that almost all of the unflattering published literature to-date has been authored by current or former Stryker paid consultants. This most recent paper analyzes the patients of Dr. Stephen Incavo who implanted about 100 Rejuvenates all during a period when he was a paid Stryker consultant.
Those of us who have represented clients in past and currently ongoing failed hip implant litigation are used to the company’s paid consultants circling the wagons and publishing literature that generally suggests that the devices perform well if they are implanted correctly. If true, that suggests that the device failures are related to surgeon error as opposed to a faulty design. Here however, Stryker’s go-to, key opinion leaders who they paid tidy sums to represent the company and consult on product design etc. are leading the way in the scientific and orthopedic community condemning this device. One can scour the literature and not find a single published article that is flattering or supportive of the Rejuvenate or ABG II implants. Not one.
Dr. Incavo’s scientific analysis of his patients’ data suggests that only 40% of these devices will survive in the patient for four years or more. That means he is predicting that 60% will fail at four years or more.
For those of us representing large numbers of these patients we hope the literature focus quickly shifts to describing how badly these recalled devices have hurt patients. My clients are left wondering what the long term effects of cobalt and chromium poisoning mean to them. Since many of these patients are young a large number of Rejuvenate recipients have to worry about that for decades.
