At Cantillons Solicitors, we have represented clients who have encountered problems following hip and knee replacement surgery.
Problems can arise because of:
- Defective Product
- Surgical Error
- Post Operative Management
Issues that we have encountered with joint replacements have ranged from problems with the design of the new joint to surgical mismanagement. Such mismanagement may have occurred, pre, intra or post operatively.
LEGAL ISSUES
There are two particularly important aspects to litigation arising from defective orthopaedic devices. Firstly, there is potential product liability against the manufacturer under the Defective Products Act 1991, for its poor design and/or poor choice of materials.
Secondly, there is a potential liability for medical negligence against the HSE (or private hospital) and the operating orthopaedic surgeon arising from the insertion of the hip or other orthopaedic product and follow up care.
Product liability and medical negligence are extremely complex areas of the law and require specialist experience on the part of the legal advisor. With our cumulative product liability and medical negligence experience, Cantillons Solicitors is the firm which legal colleagues recommend if such a query arises.
STATUTE OF LIMITATIONS/TIME LIMITS
It is important to note the law in relation to the Statute of Limitations (time limits) within which a case can be taken is generally two years from the date of the insertion of the defective device. In some situations the time can be extended for those who did not have knowledge of the wrongdoing (or alternatively that the person did not have knowledge that the wrongdoing caused the injury).
It is always best to move expeditiously and we would advise that if proceedings are going to be issued, such proceedings should be issued as soon as possible.
For further advice on these issues, you are strongly advised to contact Cantillons Solicitors immediately in order to ascertain what the specific time limit is in your own case.
STORAGE/EXAMINATION OF THE REMOVED IMPLANT
If your orthopaedic implant has been removed during the course of revision surgery, we at Cantillons Solicitors will make arrangements for the implant to be stored pending the outcome of any litigation. It may also be necessary to arrange to have the removed implant examined by an Independent Expert.
RECALLED HIP IMPLANTS
In recent times, there have been a number of hip explants or devices withdrawn from the market:
DEPUY ASR RECALL
We have been consulted by a large number of persons who have had defective DePuy ASR hips installed. Our investigations have led us to believe that in a number of instances, these problems have arisen because of the defective product and/or surgical mismanagement. This has caused considerable pain and suffering for those affected.
The background to the DePuy ASR recall is that on the 26th August 2010, DePuy Orthopaedics Inc recalled their ASR hip resurfacing system and ASR total hip replacement products from the worldwide market. (These products had been withdrawn from the Australian market in December 2009 and from the US market in March 2010.)
DePuy announced that five years after implantation, 12% of patients who had received the ASR resurfacing system and 13% of those fitted with the ASR total hip replacement needed a revision surgery. A 2012 article in the British Bone and Joint Surgery Journal has suggested that the failure rates may be up to 50% over 6 years.
Due to the earlier than expected failure rates of the implants, patients began experiencing intense pain and weakness of the hip, including swelling and problems with mobility.
The ASR system which is a metal on metal implant (as opposed to the older ceramic model) has led to very specific problems, as the grinding of the movable metal parts of the implant have been shown to release metal ion particles (specifically Cobalt and Chromium) into the blood stream.
Symptoms suffered by patients who have been implanted with the DePuy ASR hip devices include:
- Severe Pain,
- Weakness of Hip Joint,
- Swelling of Hip Joint,
- Reduced Mobility,
- Metalosis (soft tissue damage due to exposure of metal),
- Necrosis (premature death of body tissue) or
- Elevated Cobalt and Chromium metal ion levels.
The full extent of the potential damage that is caused by this cobalt poisoning or metalosis is as yet unknown. However, it may result in the formation of non-cancerous tumours, sinew damage and aseptic lymphatic vascular and associated lesions.
According to the HSE, over 3,500 patients have been fitted with these recalled DePuy hip devices since 2004.
SMITH & NEPHEW R3 ACETABULAR SYSTEM
On the 1st June 2012, Smith & Nephew Orthopaedics initiated a market withdrawal of metal liners from the R3 Acetabular System due to a higher than expected number of revision surgeries associated with the use of the device in total hip replacements outside the US.
Smith & Nephew is recommending that Physicians maintain their usual follow up protocol for patients who have undergone total hip replacement or resurfacing surgery. The decision to withdraw the device came after a review of clinical results showed 1.6% of patients implanted with the system required revision surgery annually, above the 1% guidelines set by Britain’s’ National Institute for Health & Clinical Excellence.
Approximately 7,700 metal liners have been implanted since the component was introduced in 2007. This number would include a small number of Irish recipients.
DEPUY ADEPT 12 – 14 MODULAR HEAD
On the 15th January 2013, DePuy, a Johnson & Johnson company issued a Field Safety Notice in respect of the ADEPT 12-14 modular head used in total hip replacements after reviewing its revision rates in the UK National Joint Registry Supplier Feedback Data and the Australian Orthopaedic Association National Joint Replacement Registry. The Notice does not apply to the ADEPT hip resurfacing femoral components.
Finsbury Orthopaedics Limited designed, developed and manufactured the ADEPT 12-14 modular head in 2004. DePuy acquired the firm in 2009.
The implant has a cumulative revision rate of 12.1% at 7 years, according to results analysed from the U.K. National Joint Registry Supplier Feedback data in November 2012. In the Australian Orthopaedic Association National Joint Replacement Registry, Registry Officials reported a 7.1% cumulative revision rate for the modular head of 3 years when used in total hip replacement, according to an analysis done in September 2012.
The recall involves 7,700 implants sold in 21 countries.
FURTHER ADVICE
If you are a patient affected by any of the above hip implant recalls, or if you have concerns about your orthopaedic device or the manner in which your orthopaedic surgery was carried out, contact the Medical Negligence Team by calling Cork 021 4275673 or Dublin 01 264 1802 or email your query to info@cantillons.com
We have over 50 years cumulative experience in advising clients when medical treatment goes wrong. We recognise that this is often a very distressing and difficult experience. We are experienced listeners, we ask the right questions and we give clear and thoughtful advice as to whether a case can be pursued.
* In contentious business, a Solicitor may not calculate fees or other charges as a percentage or proportion of any award or settlement. Many Personal Injury Solicitors portray themselves as “no win no fee Solicitors Cork”. This term can be misleading and it is essential that you discuss fees with the Personal Injury Solicitor you ultimately choose. At Cantillons Solicitors, we are entirely transparent.
