According to orthopedic experts, we have only seen the tip of the iceberg when it comes to painful revisions for failing hip metal on metal implants. Poor patients, they were sold a bill of goods from the orthopedic device manufacturers and the orthopedic doctors who peddled their costly implants.
In total hip replacement and hip resurfacing, particle debris from the cup and ball can cause implant failure. As the implant patient moves, the surfaces of these two components grind against each other. The friction and abrasive wear and tear leads to debris production. Experts estimate that every step taken with a hip implant produces between 100,000 and 1 million particulates of debris.
Different hip implant materials can cause different long-term complications. Metal-on-metal hip implants, where both the femoral component and the cup are made of metal, will create ionized metal debris, leading to metallosis. Device makers make implants out of several metals, including cobalt, chromium, titanium, nickel and molybdenum.
Metal-on-plastic implants, made of a metal femoral component and a plastic cup, lead to polyethylene particles that causes osteolysis or hip bone loss.
The full extent of metallosis complications are not fully known, it has been linked to side effects, including:
- Severe joint pain
- Implant failure
- Implant loosening
- Local tissue necrosis
- Deterioration of the bone around the implant
- Cysts and pseudotumors
Johnson & Johnson DePuy Pinnacle $502 Million Verdict
Recently, a Texas federal jury in Dallas has awarded $502 million total to five separate plaintiffs after a lengthy consolidated trial involving defective Pinnacle Hip Implants manufactured by DePuy Orthopaedics and Johnson & Johnson (J&J).
DePuy Orthopaedics and Johnson & Johnson was found liable hiding flaws in its Pinnacle line of metal on metal artificial hips that caused the devices to fail prematurely and left them facing revision surgeries and pain.
The jury found that the hips sold by J&J’s DePuy unit under the Pinnacle brand name were defective and company officials knew about the flaws but failed to warn patients and doctors of the risks.
They awarded $142 million in actual damages and $360 million in punitive damages to a group of five patients whose hips broke down and had to be surgically removed.
J&J DePuy Hip Implant Failures
Johnson & Johnson’s DePuy Orthopaedics subsidiary continues to face thousands of lawsuits over their defective metal-on-metal Pinnacle hip replacement.
According to the latest court data from May 16, 2016, there are more than 8,356 federal product liability lawsuits that have been filed by folks who experienced severe and serious side effects with the artificial hip implant.
DePuy has a track record of early hip implant failures stretching back more than 10 years. DePuy’s 2010 recall involved the company’s Articular Surface Replacement (ASR) Acetabular Hip System and ASR Hip Resurfacing System. Like other hip devices with metal components, they were marketed as cutting-edge designs that offered better durability and more mobility than older devices.
DePuy recalled its hip systems after data from the U.K. joint registry revealed that metal devices are no more durable than older devices and had more side effects including a much higher failure rate at 5 years. In 2013, the jury in the first ASR trial found that at the time of the recall, DePuy knew that within five years, more than 40 percent of its ASR implants would fail.
Federal DePuy Pinnacle Multidistrict Litigation
Since 2011 all federal DePuy Pinnacle cases has been consolidated and centralized in the U.S. District Court for the Northern District of Texas, as part of an MDL, or Multidistrict Litigation.
The first bellwether trial in 2014, found for the defense when the jury found that the patient injuries may have been as a result of poor doctor implant techniques.
DePuy Pinnacle Hip Problems
Thousands of similar lawsuits allege that the DePuy Pinnacle hip has an unreasonably dangerous and defective design, which was not thoroughly studied and that inadequate warnings were provided about the risk that the device may loosen and fail.
The jury found that DePuy took a number of short cuts getting the Pinnacle hip implants on the market, in part due to the 510(k) approval process, which only requires a device be substantially equivalent to devices already in use.
The company did not seek premarket approval, and so avoided the FDA requirement to determine if a device is safe or effective. There were no Pinnacle hip clinical trials to see if it even worked, or if it was safe to use.
The FDA released new guidance for metal-on-metal hip replacements in January 2013, indicating that doctors should only use the design if other artificial hip implants are not appropriate. The agency also determined that future metal-on-metal hip designs will be required to undergo extensive human clinical trials before they will be approved.
5 Comments
howard piper
Hi. I am reading your Hip analysis ' experts say -100,000 to 1 million particles of debris'. I am in London, collaborating with research that might add systemic cobalt poisoning to your list of injuries. We might usefully exchange information. It could help me to know which expert paper you are referring to above so we can link in. I can update you on our research - being prepared for nuclear journal publication at the moment.
Chuck Higgins
I have both of my hips outfitted with the Birmingham Hip Resurface. I am 45yo (40yo at the time of the implants), 6'1", 175#, with an athletic build. I was in the sweet spot for the procedure. I haven't had any issues. In fact, I am still playing competitive soccer and mountain biking like a champ!
I get emails forwarded to me by my friends, referencing hip implant recalls. I always have to rebut by stating that it's the DePuy/J&J product that is getting the heat, not the BHR, although the BHR is not doing too well in non-athletic, fat women (read: most American women).
Lynne
The BHR has ruined my life. I was young and fit when I had it fitted,.now I can only walk a little using a crutch
David
I have a metal on metal R hip implant that was put in for in 2006. 10 years and still feels great. Probably stronger than my other hip. During all of my research, this comes down to the surgical technique. Less skill = less success. More skill = more success.
Bryan Vroman
I had the BHR done on my right hip at the age of 25. In the first year of having it, it was showing signs of failure. By 29 it was revised (Now 32). I guess that I was not in the "sweet spot" age group. I did not/still do not have a desk job. I have worked with my hands for the past 12 year's of my life building/remodeling house's. I'm 5'11" 160lbs, I must not fall into the "athletic" .....maybe the "fat" group? Mr Higgins must be blessed.
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