Gentamicin is an antibiotic that is mixed with DePuy Orthopaedics bone cement used in knee, shoulder, and hip replacement surgeries to stabilize the bond between the implant and the bone. The Gentamicin is added to the cement to prevent infection at the site of the joint replacement. Unfortunately, the addition of the antibiotic can cause the cement to fail, resulting in the patient suffering additional pain and often needing expensive and painful revision surgery.
Problems Patients Suffer When Gentamicin Bone Cement Is Used
The addition of Gentamicin to DePuy cement products can cause the cement to weaken and in some cases, cause the implant to detach completely from the bone. In addition, use of Gentamicin can result in the following side effects:
- Cardiac arrest
- Dangerously low blood pressure
- Heart attack
- Pulmonary embolism—the blocking of the arteries in the lungs often caused by blood clots
- Renal failure
DePuy created different types of Gentamicin bone cements to be used in replacement surgeries. Dangerous cements they manufacture include:
- BioStop® Bone Cement Restrictor
- Smartset® GHV and GMV
- DePuy CMW2 Generator and Bone Cement 20g
- Smartset® HV and MV Bone Cement
Since January 2011, the U.S. Food and Drug Administration (FDA) have received over 150 adverse event notifications from consumers, doctors, and other medical professionals that Gentamicin bone cement is causing serious injuries and complications. In October 2013, the FDA issued a recall of SmartSet® GMV Endurance Gentamicin products after the manufacturer voluntarily recalled it. It was discovered that Smartset® GMV Endurance Gentamicin had not been approved for certain uses by the FDA. Despite the well-known risks of using these cement products, doctors continue to utilize them.
Have you suffered problems after a joint replacement surgery where a Gentamicin cement product was used? If so, you may have a medical malpractice claim and a products liability suit. Fill out our online form to schedule a free consultation to learn more about how we can help you.