If you are undergoing a serious medical procedure such as a knee replacement, you need to trust both the surgeons and the equipment they use.
However, according to a recent alert from the Department of Health’s Therapeutic Goods Administration, there are potentially a number of patients who have had non-sterile implants inserted during knee replacement surgery in Australia.
The risk involves Duracon augments tibial wedge implants manufactured by Stryker Australia. These implants are commonly used to replace bone or address other knee problems as part of surgery.
According to the National Joint Replacement Registry’s Supplementary Report 2014, there were over 50,000 knee replacements undertaken in 2014 – 3.4 per cent higher than in 2012.
Where does the risk manifest?
Like many medical products used in surgery, Duracon augments tibial wedge implants come in sterile packaging that remains sealed until it is needed. Despite this fact, the Therapeutic Goods Administration notes two overseas examples where the implants have pierced its packaging and been exposed to the air.
Fortunately in these cases, medical professionals caught these breaches before the surgery and used a different implant.
In Australia, a number of these implants were used before this risk was identified and a number of patients may have suffered a post-operative infection as a result.
“The Instructions for Use for these implants require that operating room staff inspect the package for damage before implantation and to not use the implant if any is identified,” the hazard alert read.
What is the next step?
Stryker Australia stated that all the potentially affected Duracon augments tibial wedge implants have been inserted into patients. While the risk of the implant being non-sterile is low, there is still the chance that a post-operative infection occurs.
The Therapeutic Goods Administration said patients or their families who are concerned about this medical risk should get in contact with their surgeon or the hospital where the operation took place.
Surgeons who use the implants have been contacted by Stryker Australia of the risk and were advised to continue normal post-operative treatment.
Medical negligence compensation
Patients that developed further complications due to mistreatment surrounding non-sterile implants could be eligible for medical negligence compensation. These individuals are urged to contact a lawyer who can help them with their claim.
As medical negligence compensation is a complex situation, it is best to take your claim directly to a lawyer. It is also important to record anything that could help your claim. If your negligence lawyer has access to all relevant information, then you are more likely to be successful in your case.