Metal-on-Metal Hip Risks Lead FDA to Require PMA to Remain on Market
The FDA now requires metal-on-metal hip implants to go through the full premarket approval process due to concerns over complications and high failure rates.
The FDA now requires metal-on-metal hip implants to go through the full premarket approval process due to concerns over complications and high failure rates.
A number of patients have reported experiencing problems with certain metal-on-metal Biomet hip replacement implants, which may result in the need for additional surgery to revise or replace the artificial…
Several groups representing orthopedic surgeons have reached a consensus statement that indicates metal-on-metal hips are up to three times likely to fail as other designs.
A new study finds that nearly a quarter of all hip implant components on the market are untested for clinical effectiveness.
Plaintiffs and defendants have filed competing scheduling plans that disagree on when Biomet Magnum hip bellwether trials should begin.
Recent problems with a variety of FDA-approved medical devices are leading a prominent consumer group to call for more stringent testing requirements for high-risk implants, such as metal-on-metal hip replacements…
Federal health regulators confirmed yesterday that problems from metal-on-metal hip replacements may result soft tissue damage and other complications as metal particles are shed into the body, resulting in new…
Federal regulators are dragging their feet on industry requirements that could prevent dangerous and defective metal-on-metal hip replacement systems from getting to the market, according to an editorial in a…
A motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation to consolidate and centralize all federal Biomet Magnum hip replacement lawsuits, which allege that design defects with…
A new study indicates that individuals who received metal-on-metal hip replacements may be at an increased risk of suffering severe inflammations that resemble tumors, adding to the existing concerns for…