Returning home from a four-day trip, having to do with updates in Regenerative Medicine, I was confronted by numerous inquiries from patients in whom I have performed joint replacements. The issue, prosthetic recalls. Since I have performed in excess of 20,000 hip and knee replacements over my surgical lifetime both here and abroad, communication between my staff and my patients is ongoing but the recent increase in questions concerning these prosthetic recalls prompted me to redirect the Blog this week.
Recently, there has been a marked upturn in advertisements by plaintiff attorneys soliciting patient clients for legal action involving real or alleged recall of products by Zimmer, Stryker, and Johnson and Johnson. Many of these advertisements presumably have been inspired by media coverage and the plaintiff attorney solicitations are increasingly disruptive to my practice and disturbing to patients who have undergone, or are considering undergoing joint replacement surgery. I will try to correct the misleading and false claims in the public domains and educate my patient and my Blog subscriber. While it does appear though that there are situations wherein manufacturers of hip devices have placed profits over patient safety, many of the ads are misleading, and some are deliberately wrong.
Depuy Orthopedics, a division of Johnson and Johnson, recalled two of its hip replacement products, 1) the ASR XL Acetabular System and the ASR Hip Resurfacing System. 12 –13 percent of patients needed a second hip replacement within five years of receiving an ASR implant. I have personally never used an ASR implant.
Similar to Depuy Orthopedics, the Zimmer Durom Cup was recalled in 2008 after hundreds of patient complaints that the product was defective and required early revision surgeries. I have personally never used a Zimmer Durom Cup
I became aware of the early failures of Stryker Trident PSL and Hemispherical Acetabular Cups before the company announced its recall because I had to revise several of my own patients in a relatively short time after implantation. Problems included poor fixation, improper seating of components and bone fracture due to a nonconforming product. Stryker recalled its defective Trident cups in 2008 after numerous warning letters from the FDA; the company new about the defective manufacturing process in Cork, Ireland several years prior to its acknowledgment.
Media coverage describing the negative experience of a single surgeon using the NexGen CR-Flex Porous Femoral Component have prompted an increasing solicitation of potential clients for legal action against Zimmer. What prompted that surgeon to continue using the device when it was quickly apparent they weren’t working is a fair question but beyond the scope of our Blog? There has never been an action involving an alleged recall of products in the Zimmer NexGen category, the FDA has never ordered such recall. I have never personally used a NexGen CR-Flex Porous femur.
You may learn more about a particular orthopedic company or product on the web; access the corporate website: Stryker, Zimmer, Johnson and Johnson, Depuy.