MassDevice reports that Signal Medical Corp., a Michigan-based medical device manufacturer, has received a warning letter from the U.S. Food and Drug Administration (FDA) regarding unapproved changes to its hip implants. According to the letter, Signal Medical included a hood liner in its MicroSeal total hip acetabular system that did not receive premarket approval with the MicroSeal implant. The violation was discovered during inspections in July and August 2014. Signal Medical responded to the FDA’s initial warning in August, but the agency was unsatisfied with the actions taken, and sent another warning in December.
British-based medical device manufacturer Smith & Nephew experienced a similar issue in June 2012, when it recalled the optional metal liner component of its total hip replacement device, the R3 Acetabular System, due to unreasonably high rates of failure. Like Signal Medical’s hood liner, the R3 metal liner, which is inserted into the hip implant’s metal pelvic socket, did not receive premarket approval from the FDA for use with the R3 Acetabular System. Plaintiffs in Smith & Nephew hip replacement lawsuits are now claiming that the unapproved combination of these devices led to serious health problems, including fractures, dislocation of the implant, and infection of the tissue around the hip joint.
Along with Signal Medical and Smith & Nephew, Zimmer Holdings, Inc., has come under fire for its defective hip implants. The Indiana-based company introduced its Durom Acetabular Component, or Durom Cup, in 2006 for use in total hip replacement systems. The Durom Cup was quickly recalled, however, after reports of high failure rates. It is estimated that as many as 2,000 patients who received a Durom Cup implant will have to undergo revision surgery, which is both painful and costly. Plaintiffs in Zimmer hip replacement lawsuits allege that the Durom Cup was defectively designed and is prone to deterioration and dislocation. In June 2010, 240 Zimmer hip lawsuits were consolidated in a multidistrict litigation in the U.S. District Court for the District of New Jersey.
Medical device manufacturers have a duty to protect the health of the patients treated using their products. The attorneys at Lopez McHugh are dedicated to helping patients who have been injured by defectively designed medical devices. If you or a loved one was injured by a failed Smith & Nephew or Zimmer hip replacement implant, contact our team of hip implant lawyers today to receive a free consultation. We can help you determine whether a Smith & Nephew or Zimmer hip replacement lawsuit is right for you.