Excessive Rubbing Leads to Metallosis
Manufactured by Encore Medical, the Encore metal-on-metal hip implant is yet another device where patients have suffered metallosis and implant failures similar to those that resulted in the recalls of the DePuy ASR, the Zimmer Durom Cup, and the Smith & Nephew R3.
The Encore hip implant with its “poly sandwich” design has a metal insert on a polyethylene (plastic) liner in the acetabular shell, which is the ball-shaped part of the implant that fits into a patient’s own hip socket. The liner is made of cobalt chromium.
As with the other recalled products, as a patient walks (or bears weight on the joint), the ball and the cup of the hip implant rub together. This constant rubbing causes an accumulation of cobalt and chromium debris in the hip joint area, which can then lead to a serious condition called metallosis.
Encore hip implants include a “monoblock” design, which is a one-piece neck and stem and “modular” hip stem where the stem and neck are two pieces. Both types of devices have the potential for this excessive rubbing.
Encore Hip Implant Complications
In addition to metallosis, complications can include:
- Elevated levels of cobalt and chromium in the blood
- Inflammation and swelling
- Limited mobility or flexibility
- Formation of Pseudotumors
- Loosening or dislocation
- Revision surgery
Questionable FDA Fast Track Process
Encore’s unique design, referred to as a “poly sandwich,” which includes the polyethylene and metal inlay, was approved by the FDA under the 510(k) “grandfather” provisions.
What this means is that Encore only had to demonstrate that its hip design was “substantially similar” to pre-existing designs in the marketplace and as such be exempted from major testing. Unfortunately, “similar” does not mean safe and this fast track process has led to many defective and poorly designed hip implants over the past several years.
Time to Get Legal Advice?
Hip implant manufacturers need to be held responsible for properly designing a device, manufacturing it and testing it, and should issues arise, they should proactively warn the public that a device is faulty, has adverse side effects or doesn’t do what it is supposed to do.
If you are planning to have revision surgery for your Encore hip implant, talk with a lawyer first. It is essential to take possession of the implant as soon as it is removed to preserve it as evidence for your case. Pathology specimens may also be needed to document the amount and effect of the metal debris.
We are a leading national law firm in the area of hip replacement litigation. Our attorneys have extensive experience handling hip replacement and knee replacement lawsuits, obtaining over $50 million in Collective Settlements involving defective knee and hip replacements.
Receive A Free Evaluation
The Nash & Franciskato Law Firm is currently accepting Encore hip implant-related injury cases. If you or someone you know has been diagnosed with metal poisoning or needed a revision surgery, contact us for a free, no-obligation case evaluation.
Metallosis, also known as adverse local tissue reaction (ALTR), involves the deposition and build-up of metal debris in the soft tissues of the body. This condition can be caused when metallic components in medical implants, such as joint replacements, rub against each other.
Metallosis can cause damage to the surrounding tissue, swelling in the area of the implant, fluid buildup, and pseudotumors (soft tissue growths). Often this leads to revision surgery.