Biomet’s M2a Magnum hip replacement has been included in the Food and Drug Administration’s (FDA) watch list because of the disturbing number of reported complaints from patients and hundreds of Biomet lawsuits filed in the United States, an online source reveals.  A consolidation of M2a Magnum lawsuits took place on October 4, 2012 by the judicial panel of multidistrict litigation headed by Judge Robert Miller, says a report published in dockets.justia.com/docket/indiana/inndce/3:2012md02391/71286/. M2a Magnum is a metal-on-metal hip replacement by Biomet Orthopedics. It used to be the company’s in-demand medical device among its line of products but has recently been receiving negative feedbacks from patients who claimed that its design was defective, causing metal toxicity and early failure.

Originally, Biomet disagreed that an MDL was needed, arguing that the M2a Magnum failure rate is not as high compared with other metal-on-metal hip replacements from other manufacturers. Furthermore, the subject of these lawsuits was never recalled unlike what happened to DePuy’s ASR XL, which was subjected to a pullback in 2010.

The judicial panel, however, declined Biomet’s motion, explaining that although Biomet has settled lawsuits in the past, there were 308 cases that were already included in the MDL and most of them are opting for litigation in court.
These patients have even contacted a Biomet lawyer to represent them in court.

For more information, please visit: Plaintiffs Who Moved to Centralize Biomet M2a Magnum Hip Lawsuits From California

 
 

One of the popular makers for reconstructive medical devices, such as hip replacement implants, is Biomet.M2a-Magnum is a Biomet-produced metal hip replacement that aims to provide absolute range of motion, offering the potential of 160 degrees range of motion.People think that surgery causes the main problem; however, there are some who believed that the implant itself causes problems, reported an article from ehow.com/facts_7670168_biomet-hemiarthroplasty.html.

There have been reports of acetabular cup loosening, bone loss, chronic pain, and metallosis that are linked to this metal-on-metal hip replacement device. In 2009, 11 adverse event reports have been gathered by the US Food and Drug Administration.In 2011 alone, it has nearly increased eight times, letting the FDA received 80 adverse event reports for this device.

Recently, there are a number of adverse event reports linked to the implant that is received by the FDA. The Biomet M2a-Magnum is a metal-on-metal hip implant in which patients alleges was not properly tested by Biomet. Because M2a-Magnum has no option for acetabular cup liner, it allegedly causes metal to rub against metal with the full weight and pressure of the human body.

A ball, stem, and shell composed a metal-on-metal hip replacement implant.Walking or running creates friction against the metal ball and cup. The other parts of the implant where two implant components connect may generate metal particles. A patient may experience wear and corrosion between the metal ball and taper of the stem.There is a potential that these metal debris may seep into the bloodstream.

On May 6, 2011, the FDA issued a post-market surveillance study of total metal-on-metal hip replacement devices. After the medical device has been approved or cleared by the FDA, a post-market surveillance helps the agency to monitor the device’s adverse effects.Manufacturers of metal-on-metal hip implants have orders from the FDA to further study the safety of metal-on-metal devices. You are recommended to consult your surgeon on a regular basis if you are using a metal-on-metal hip implant, to monitor how well your device is functioning.

References:

fda.gov/Medicaldevices/productsandmedicalprocedures/implantsandprosthetics/metalonmetalhipimplants/ucm241604.htm
blog.thomsonreuters.com/index.php/biomet-m2a-magnum-hip-device-suits-centralized-before-indiana-federal-judge/
biomet.com/patients/m2a_magnum.cfm
fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/default.htm
ehow.com/facts_7670168_biomet-hemiarthroplasty.html