Recent warnings released by the Food and Drug Administration (FDA) about any hip recall as well as metal on metal hip implants, highlight potential concerns about previous FDA hip recall announcements. People that have had a metal on metal or any hip implant that was subject to a hip recall may potentially experience problems including pain, loss of mobility, possible revision surgeries and/or metallosis. Please take the time to learn the facts about a hip recall, how it could affect you and about any statute of limitations (SOL) that could limit the amount of time you have to seek possible financial compensation. To arrange a free consultation, please call our toll-free number now.
FDA Hip Recall History
A hip recall can be announced by the FDA for any number of reasons that may or may not indicate the potential for a possible revision surgery. A list of products subject to a hip recall can be found by visiting the FDA’s website. If you have had a hip implant and are unsure of the kind of prosthetic implanted, you should consider requesting the information from your surgeon. The information is rightfully yours and should be available in your surgical/medical records. If you are unable to obtain the necessary information a hip recall lawyer, once retained by you can request a copy of your medical records. If you have concerns and would like to arrange a free consultation, please contact us today by contact form or our toll-free number.
According to the FDA “On June 1, 2012 Smith & Nephew Orthopaedics initiated a market withdrawal for metal liners of the R3 acetabular system due to a higher than expected number of revision surgeries” however the number of actual revision surgeries performed may vary inside the US from those performed outside the US. According to the FDA announcement “In the US: The R3 metal liner is only approved for use with the Birmingham Hip Resurfacing System. The R3 Acetabular System is a total hip replacement system component that is not cleared for use with the R3 metal liner.”
The FDA announced a hip recall two years earlier of the DePuy ASR XL Acetabular System. The FDA’s website says “On Aug. 24, 2010, there was a voluntary recall of the DePuy ASR TM total hip system because of new, unpublished data from the UK joint registry indicating the revision rates within 5 years were approximately 13 percent.”
More recently, Stryker Orthopaedics announced a voluntary hip recall of their Rejuvenate and ABG II modular-neck stems. The FDA issued their Stryker hip recall announcement in July of 2012 which said “Stryker Orthopaedics’ decision to voluntarily remove Rejuvenate and ABG II modular-neck stems and terminate global distribution of these products comes after continued post-market surveillance. The post-market surveillance data may be predictive of a trend.” Following this action, we will work with the medical community to better understand this matter as we continue to evaluate the data,” said Simpson. Stryker has notified healthcare professionals and regulatory bodies of this voluntary recall. Patients who received a Rejuvenate Modular or ABG II modular-neck stem are encouraged to contact their surgeon. Patients uncertain if they have one of these products implanted should contact their surgeon or consult their medical records.
Reports indicate patients at the greatest risk of need of revision surgery are those that have had a metal on metal hip implant. However, there are concerns that the use of metal components including metal and ceramic or metal and plastic hip implants may lead to pain, swelling, gait changes, loss of mobility and metallosis, a potentially serious condition caused by the release of metal ions into the surrounding tissues or reportedly, the blood.
Typically a hip implant should offer more mobility and a reduction in pain and should be expected to last about 10 years or more. When a hip implant device is faulty or does not function properly, the risk of additional surgery within a 5 year period increases. Revision surgery can be more risky and take longer to heal than an initial hip replacement surgery. According to Mathias P. Bostrom, MD, Attending Orthopedic Surgeon, Hospital for Special Surgery; “It is well established that there is more morbidity associated with revision in the setting of severe tissue loss,”
Johnson and Johnson is reportedly facing over 10000 hip lawsuit cases and has now announced they will discontinue the sales of all metal on metal hip implants and metal on ceramic hip implants worldwide. A public statement published by Bloomberg on May 17, 2013 says “Johnson and Johnson(JNJ) the world’s biggest maker of health-care products, said it will stop selling metal-on-metal and ceramic-on-metal hip replacements as demand wanes for the devices and U.S. regulators seek new rules.”
Other hip implants that reportedly carry an increased risk of potential for revision surgery include the Biomet M2a-Magnum Hip, Stryker Trident, DePuy ASR, DePuy Pinnacle and the Stryker Rejuvenate and ABG hip implants. Some of these may not be included in a hip recall. If you have questions about a hip recall you can arrange for a free consultation with a hip recall lawyer by filling our contact form (provided) or by calling our toll-free number. Please be aware that your time may be limited for filing a hip recall lawsuit.