Defective Medical Device

Representing the Injured in Kentucky and Tennessee

Serious injury and aging are the main causes necessitating joint replacement procedures. There are over half a million of these procedures performed every year in the U.S. alone.

Total joint replacement (TJR), also known as arthroplasty, utilizes modern polymers and advanced techniques to create artificial joints capable of mimicking the natural actions of the human body while alleviating the extreme pain caused by musculoskeletal conditions such as rheumatoid arthritis or joint damage following or caused by serious injury.

Musculoskeletal conditions are the most common worldwide cause of severe long-term pain and physical disability, accounting for $254 billion in medical expenditures in the U.S. every year (1). Musculoskeletal conditions are the impetus of over 130 million annual healthcare visits and by 2010 will be responsible for 25% of all healthcare expenditures in developing nations (2). One out of every seven Americans incurs a musculoskeletal injury every year.

Defective Implant Devices
DePuy International Ltd, a subsidiary of Johnson & Johnson, first introduced Hylamer® as an “implant-grade” polyethylene (an engineering thermoplastic which becomes pliable when warmed and hard when cooled) in 1990 designed specifically to reduce wear in TJR devices and reduce bone degeneration (osteolysis) around the implant.

Hylamer was initially sterilized by gamma-irradiation in air. The presence of oxygen during gamma sterilization and storage is known to cause progressive oxidative degeneration of “implant-grade” polyethylene and is associated with decreased wear resistance and brittleness. Hylamer is suggested to be more susceptible to oxidative degradation than conventional polyethylene used in joint replacement implants (3). This essentially means that the process used to sterilize these parts was flawed and made them unsafe for implantation into people.

The defective nature of these components resulted in many patients being forced to undergo yet another surgical joint replacement procedure, exposing them to unnecessary risks.

Medical Warnings
The Medical Devices Agency (MDA), a division of the Medicines and Healthcare Products Regulatory Agency (MHRA) of England issued a recall of all Hylamer products sterilized by gamma-irradiation in air. In a September 2001 safety warning to all hospitals and physicians suggesting the recall of all Hylamer components they stated, “It is possible that patients who have received affected Hylamer implant components that have been sterilized by gamma-irradiation in air my experience higher wear rates than normal and there may be a risk of premature implant failure, resulting in the need for clinical intervention or revision.”

This warning was issued following a review of patients at one hospital which showed a failure rate of 67.7% after five years; the standard set by the National Institute of Clinical Excellence is only 5% at the five-year mark, which means the failure rate of these devices was higher than 62 times the institute mandate.

What should I do if I received a defective joint replacement component?
Always consult your doctor or physician regarding health-related issues. If you or someone you love received defective joint replacement components and had to have another surgery to correct this condition, we would like to speak with you right away. Call us or fill out a free online consultation form for an immediate evaluation of your case.

Sources:

1) Dorothy Rice, ScD (Hon), "Musculoskeletal Conditions: Impact and Importance," presentation to Bone and Joint Decade Committee, June 7, 2000.

2) The United States Bone and Joint Decade (www.usbjd.org) Facts & Figures.

3) Collier J, Bargmann L, Currier B, Mayor M, Currier J and Bargmann B. An analysis of Hylamer and polyethylene bearings from retrieved acetabular components, Orthopaedics 1998, Vol 21 (8), 865-871.

4) Yamauchi K, Hasegawa Y, Isawada S, Sakano S, Kitamura S, Warashina H and Iwata H. Head penetration into Hylamer acetabular liners sterilised by gamma in air and in a nitrogen atmosphere, Journal of Arthroplasty 2001, Vol 16 (4), 463-470.

5) Yau S, Essner A, Schmidig G and Wang A. Effect of gamma sterilisation in air and shelf ageing on wear of enhanced an conventional UHMWPE acetabular cups, ORS 2000, 46th Annual Meeting, Orlando, USA.

6) Schmalzreid T, Dorey F, McKellop H. The multi-factorial nature of polyethylene wear in-vivo. J Bone Joint Surg, 1998, 80A(8), 1234-1242.

Hylamer® is a trademark of DePuy International Ltd and is used here only to identify the product in question .

This law firm is not affiliated with, sponsored by or associated with DePuy International Ltd, Johnson & Johnson, the Medical Devices Agency or the Medicines and Healthcare Products Regulatory Agency.

Have you or someone you love been injured? Contact a Hughes & Coleman injury lawyer today! We have offices in Bowling Green, Louisville, Lexington, Murfreesboro, Nashville, Knoxville, Chattanooga, and Clarksville. Complete a Free Online Consultation Form or call us toll free at 1(800)489-6000 to contact us today.

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