What is Wrong with the Biomet M2a and Magnum Hips?
The Biomet M2a 38 and the M2a Magnum are metal on metal hip implants with a history of serious complications. The problems reported by patients are the result of the metal head (also referred to as the “ball”) and the metal cup rubbing together and releasing cobalt and chromium debris. This metal debris has been linked to pseudotumors, tissue death, elevated blood metal ions, and systemic problems such as cancer and heart disease.
Research on Biomet Metal on Metal (MoM) hip patients finds tissue damage and pseudotumors around the joint, even when the patient has NO symptoms, like pain, clicking, or swelling. Metal reactions to Biomet Magnum and M2a hip replacements are often not seen on X-rays and blood tests, according to researchers. Some pseudotumors can only be found by performing a MARS MRI or CT scan, even when X-rays and blood tests for metal ions show nothing abnormal.
Doctors may not even consider a hip revision for Biomet MoM patients because symptoms and problems don’t always show up with standard medical testing. In one study (Bosker, et. al), out of 107 patients with Biomet M2a hips, 42 had pseudotumors (39%) but only 12% of the patients in this study had surgery to remove the Biomet implant at 4.5 years.
Adverse Reaction to Metal Debris (ARMD)
Adverse reaction to metal debris, or ARMD, includes fluid around the joint, tissue masses, and death of muscle tissue around the joint. In the Bosker study, 46 of 78 patients showed a soft tissue mass (pseudotumor) and fluid collection. Out of 80 patients, 43 showed evidence of metal debris reaction. That means 54% of the patients in the study showed signs of adverse reactions to metal debris. Symptoms included clicking in the hip, swelling, and a feeling of joint misalignment.
In 2013 a Finnish study found that patients with Biomet Magnum M2a hip replacements were having serious medical complications after their hip replacement surgery. In fact, the researchers made a strong statement about the Biomet hip:
“ARMD (Adverse Reaction to Metal Debris) is common after ReCap-M2a-Magnum total hip arthroplasty and we discourage the use of this device.”
The researchers hypothesized that a collection of anything greater than 50ppbmm of fluid from the hip joint of a Biomet patient is significant enough to diagnose the patients with AMRD.
Heart Damage – Cardiomyopathy from Cobalt Toxicity
Recently published research shows that high cobalt levels from a Biomet M2a-Magnum hip can cause irreversible heart damage. The report looked at a patient who developed heart problems 6 years after getting two Biomet M2a-Magnum implants. He had NO symptoms indicating a problem with the implants, like hip or groin pain, clicking in the joint, or loosening. But blood tests showed extremely high cobalt levels of 189ppb.
An MRI of the heart revealed serious problems with both of his heart ventricles and changes in the front and sides of the heart walls. The doctors diagnosed his patient’s problems as myocarditis of toxic origin, most likely from cobalt toxicity.
“The cardiac manifestations secondary to systemic cobalt toxicity in this patient represent a frightening consequence of MOM prosthetic wear” (Mosier, B. et al, The American Journal of Orthopedics, March/April 2016).
This form of systemic injury means the cobalt debris from the MoM hip implant can actually cause traumatic disease and injury throughout the entire body and not just in the hip area. In this case, the patient’s defective Biomet M2a-Magnum hip implants caused permanent heart damage.
Cobalt Levels Drop Drastically after Revision Surgery
A 2015 study of patients with Biomet Magnum M2a hips found a high rate of revisions. Pseudotumors were found in 38 out of 50 revision patients. Once the Biomet hip was removed, average cobalt levels in patient’s blood dropped from a high of 20.8 μg/L to a normal 1.8 μg/L within 1 year.