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DePuy Hip Implant Recall - Summer 2011 Update

On 26th August 2011, DePuy Orthopaedics, a Unit of Johnson & Johnson, a global multinational company, announced the recall of its hip implant known as the ASR XL Acetabular and ASR hip resurfacing systems. The DePuy ASR hip was an all-metal artificial hip implant implanted in 3,500 patients in Ireland. We are also investigating complaints by patients that the DePuy pinnacle hip implant with a pinnacle metal insert (also called the ultra mesh metal liner) has prematurely failed.

In February 2011 in the United States, the Food & Drug Administration, which is the Regulatory Authority for medical devices in that jurisdiction, stated that there are "unique risks" for "metal on metal" artificial hips because tiny metal ion particles can wear off and damage nearby tissue. Patients who have received all metal implants should be aware of potential symptoms which may occur after surgery and which would indicate that the device is not functioning properly. Common symptoms may include:-

-Pain in the groin.
-Hip or leg swelling at or near the hip joint.
-A limp or change in walking ability.

The latest details from the British Hip Society annual conference show a higher than anticipated early failure rate with DePuy ASR devices. The data presented at the conference showed a range from 21% revision rate at four years (potentially rising to 35% if all currently known painful implants progressed to revision) to 49% at six years for the ASR XL device. Other devices have a revision or impending revision rate at 12-15% at five years. This data indicates that up to one in two patients may be forced to undergo revision due to a high early failure rate with the DePuy ASR artificial hip.

Why are the DePuy Hip Implants Failing?

Again, the DePuy ASR implant is an all-metal implant. Expert opinion suggests that these metal implants are defective and failed due to a design flaw for two principal reasons:-

1.Firstly, the device slips or the shell does not sit in place in the hip and it resists bone growth.

2.Secondly, the friction of the metal on metal (metal hip ball and metal hip socket) causes microscopic shavings and metal debris to be released into the surrounding tissue and blood. This can lead to a painful inflammatory reaction in the tissue and high blood metal content.

DePuy has informed physicians that patients should undergo blood tests to determine the presence of metal ion particles, including cobalt and chromium released from the metal on metal implants.

For further information, read our list of answers to common questions on the DePuy hip recall.

Access to Medical Treatment

Malcomson Law was to the forefront in indicating that the authorizations prepared by DePuy and released upon their website, which were delivered for the purposes of gaining access to patients' medical records, were inappropriate. In that regard, this attempt to achieve access to such medical record detail has now been discontinued by DePuy.

A new issue has materialized in recent months which relates to maintaining the excised hip implant for the purpose of having same available if so required for analysis by a Medical Mechanical Engineer. This Firm has advised all its clients that, under no circumstances, should access be granted of the excised implant to DePuy. Also, this Firm has drafted an authorization that we believe will be acceptable to the HSE in terms of the preservation of the excised hip implant for future analysis. In that regard, if you are undergoing surgical intervention by way of hip revision then it is necessary that you inform the HSE by way of furnishing such an authorization to the relevant hospital and treating physician indicating the procedure and process to be utilized for the purpose of preserving the excised hip implant or explants.

Patient Profile

At Malcomson Law, we have met many patients where the failure of the DePuy artificial hip implant has been a life-changing event. The implants can release small particles of metal debris into patients' blood streams causing debilitating injuries. The age range of the patients affected by the defective ASR system ranges from their early 30's to early 80's. The types of indications received are that "the DePuy hip implant fiasco has altered my life significantly. I went from being an active, flexible and tireless outdoors enthusiast to a cautious, careful walker using assistance to negotiate any surface or grade. I can no longer undertake the outdoor activities that have given me so much pleasure"

Further information for a reader list of answers to common questions in the DePuy hip implant recall.

This news section contains stories of interest from publicly available news sources. Where we are representing the clients referred to in the news material we will say so. Where we do not represent individuals or bodies mentioned or quoted, the inclusion of the news story in our news section is not intended nor should it be taken to imply that we act for the individual or body concerned.