A Class II medical device recall has been issued for the DePuy Synthes Radial Head Prosthesis System, after it was determined that the radial stem may be prone to loosening at the stem-bone interface. Side effects associated with these DePuy elbow implants may include osteoloysis, pain, soft tissue damage, fracture, and poor joint mechanics.
Legal assistance is available to individuals who may have experienced DePuy elbow implant side effects associated with the Synthes Radial Head Prosthesis System recall. To obtain the help you need, please contact the nationwide law firm of Bernstein Liebhard LLP today, by calling (888) 994-5118.
DePuy Synthes recalled the Radial Head Prosthesis System in December 2016, because of concerns that the implant’s radial stem might loosen at the stem-bone interface. Several months later, the U.S. Food & Drug Administration (FDA) designated the action a Class II device recall, which indicates that the elbow implant may cause temporary or medically reversible health consequences. Some 50,311 DePuy elbow prosthesis systems distributed throughout the U.S. were affected by the recall.
DePuy Synthes was unable to determine the reason behind the radial stem loosening problems, but suggested multifactorial issues, including possible product characteristics, as well as operative and patient factors, could be at play. As such, the company was unable to formulate revised instructions to surgeons that might reduce the risk of radial stem loosening, resulting in its decision to remove the implant from the market.
DePuy Synthes has requested that customers immediately review their inventories for the recalled implants and make arrangements to return any in their possession. Patients who received a Radial Head Prosthesis System included in the recall should continue to undergo normal follow-up with their healthcare practitioner.
If this occurs, patients may experience a wide range of DePuy elbow implant side effects, including:
Because of the debilitating nature of these complications, patients who experience failure of their DePuy elbow implant due to radial stem lossening may require revision surgery to remove and replace the components, resulting in severe pain and suffering, as well as significant medical bills and lost wages. Some patients may never recover full use of their joint, even after undergoing revision of the elbow implant.
The medical device attorneys at Bernstein Liebhard LLP believe that the alleged victims of DePuy elbow implant side effects stemming from this recall may be entitled to financial compensation from the manufacturers of the device. If you or a loved one experienced radial stem loosening following implantation of the DePuy Synthes Radial Head Prosthesis System, please contact our office at (888) 994-5118 to ensure that your legal rights are protected.
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