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DePuy Hip Replacement and Resurfacing Systems
DePuy Orthopaedics, Inc., is a wholly owned subsidiary of Johnson & Johnson Medical Devices Group. The company specializes in joint replacement and resurfacing devices. At various times, devices manufactured by DePuy have been approved for use in the U.S. by the Food and Drug Administration.
However, due to the failure of its devices, the company has issued DePuy recalls and removed some devices from the market. As of 2013, the company faces more than 10,000 lawsuits, with the potential for billions of damages to be paid out in settlements and trial awards. 1
Common DePuy Hip Implant Side Effects
A February 6, 2012, review of the FDA database for medical device reports (adverse events and product problems) found that the most common side effects associated with these devices are those most common to all total hip replacements.
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These side effects include:
- Osteolysis – A condition where insufficient new bone is produced to replace old bone, leading to bone loss
Other adverse events reported more frequently in patients with metal-on-metal devices include:
- Metallosis – Metal debris incorporates and builds up in the soft tissue around the implant
- Pseudotumors – A soft tissue mass that occurs in the area of the implant due to a hypersensitivity reaction
- ALVAL (aseptic lymphocyte-dominated vasculitis-associated lesion) – Another type of local tissue hypersensitivity reaction
A review of the FDA database included 16,818 medical device reports that were received for metal-on-metal total hip replacements. 12,137 of these reports dated from 2011, of which the DePuy ASR replacement system accounted for 9,006, or 74%. This increase in events is most likely related to the recall of the device August of 2010. 2
In cases where problems are evident revision surgery, where the existing hip implant is removed and replaced with a new hip implant, is necessary. Despite these findings, hip replacement surgery remains one of the most successful surgeries in all of medicine. “The success rate for this surgery is high, with greater than 95% of patients experiencing relief from hip pain. The success rate of hip replacements 10 years after surgery is 90-95% and at 20 years 80-85%” (Haas, S. B., and T. P. Sculco. Advancements in hip and knee replacement surgery FAQs. (Aug. 12, 2005). Accessed Jan. 20, 2014.)).
Metal-on-Metal Adverse Events
Symptoms of these adverse events can be identified by one of the following:
Pain in the groin, hip or leg
Swelling at or near the hip joint
A limp or change in walking ability
Noise (popping, grinding, clicking or squeaking) from the hip joint
Total Hip Replacement with the DePuy ASR Device
The DePuy ASR XL Acetabular Hip and DePuy ASR Hip Resurfacing Systems are part of a class of large-diameter, metal-on-metal (cobalt-chrome) monoblock hip resurfacing and replacement devices. The ASR is a metal-on-metal hip, meaning that the femoral head and the acetabular cup lining are both made of a cobalt-chrome alloy, produced in different sizes to fit the needs of the particular patient. ASR stands for Articular Surface Replacement.
The ASR XL hip system was initially developed as an alternative to total hip arthroplasty. The device was intended for resurfacing procedures, and theoretically offers a greater range of motion when paired with large femoral heads. Devices of this type are most often used by surgeons in younger, more active, patients. The benefit of the device was purported to be a more stable design, thereby decreasing the chances of dislocation once the device was in place.
In 2003, the DePuy ASR Hip Resurfacing System was introduced and approved for use outside the United States only. The DePuy ASR XL Acetabular Hip System was approved and has been available internationally since 2004 and in the US since December 2005.
DePuy hip systems carry the same general risks as anesthesia and surgery, including:
A reaction to anesthesia
ASR Hip Replacement Complications
Surgical complications that occur using the ASR Acetabular Hip Replacement System and ASR Resurfacing system are similar to other types of hip replacements.
A recent FDA advisory panel also noted that hip replacement surgeries can carry other immediate, short-term or long-term complications, such as the following.
|Infection||Patients may develop major or deep infections that could require additional surgery, such as debridement (cutting out infected soft tissue) or possibly even removal of the hip device to clean out the joint. 4|
|Venous thrombosis||Deep vein thrombosis (blood clots) could develop in the pelvis or legs, especially in the thighs or calves, after hip surgery. If left untreated, the clotting could ultimately lead to pulmonary embolism, a dangerous and potentially deadly blockage of blood flow to the lungs. 5|
|Intraoperative nerve injury||Damage to surrounding nerves is a risk of nearly any surgery. Although surgeons can take precautions to avoid such injuries, harm can still occur due to accidents or unavoidable conditions during the surgery itself. Many intraoperative nerve injuries can be treated upon proper diagnosis after the surgery is complete. 6|
|Vascular injury||Although rare, hip replacement and revision surgery can damage blood vessels and cause excessive bleeding. At least one study found that risk of vascular injury is underestimated, and thus may be more harmful than thought by medical professionals. 7|
|Unequal leg lengths||After hip replacement surgery, the affected leg often may be slightly longer than it was prior to the operation. While some studies have indicated that slight lengthening (up to 2 cm) is typically not a problem for postoperative patients, 8 greater discrepancies in leg length could pose serious problems for patients in the long run.|
|Dislocation||Dislocation of the hip device can cause pain, discomfort and even psychological trauma to the patient. Most likely to happen within a few months of replacement surgery, dislocations also may damage the prosthesis and require additional surgery for correction. One study showed that a significant factor in dislocations after hip replacement is the anteversion angle, 9 but other factors also may be involved.|
|Nerve palsy||Another rare side effect stemming from certain types of hip replacement is sciatic or femoral nerve palsy. The condition may be accompanied by haematoma (internal bleeding), paresthesia (burning or prickling, “pins and needles”), and loss of dorsiflexion causing drop foot (inability to flex the foot). Symptoms can be reversed if treated quickly, but may cause chronic problems otherwise. 10|
|Implant wear||Everyday use can cause wear in the hip implant device, leading to loosening or even fracture that could require revision surgery. Also, the femoral neck (top of the thigh bone) can fracture due to additional stresses from the hip device.|
|Heterotopic ossification||One of the most common complications of hip arthroplasty, heterotopic ossification is the development of bone in muscles or other soft tissue. At least one study noted that as many as 90% of hip-replacement patients are at risk of heterotopic ossification. 11|
DePuy ASR Hip Recall
In 2010, data from an independent national registry in the UK indicated that more patients with ASR Hip System implants had undergone revision surgery than were previously reported. Within five years, approximately 12 percent of patients with the ASR resurfacing system and approximately 13 percent of patients with the ASR total hip replacement had their device revised. 12
Johnson and Johnson’s DePuy issued a voluntary recall in August 2010 in response to the UK data, one of the largest hip replacement recalls to date. The company had already begun quietly removing the certain DePuy Hip Replacement devices from the marketplace in late 2009, citing flagging sales.
- Meier, Barry. J.&J. Loses First Case Over Faulty Hip Implant. (March 8, 2013). The New York Times. Accessed Aug. 11, 2014.
- FDA report shows extent of problems with metal-on-metal hip implants. (June 21, 2012). Bloomberg News. Accessed Aug. 11, 2014.
- Sherman, D. As lawsuits climb, J&J may have new hip trauma. (July 12, 2012). Reuters. Accessed April 14, 2014.
- American Academy of Orthopaedic Surgeons. Joint Replacement Infection. (Oct. 2012). Accessed July 25, 2014.
- American Academy of Orthopaedic Surgeons. Deep Vein Thrombosis. (Jan. 2009). Accessed July 31, 2014.
- Winfree C. J. and D. G. Kline. Intraoperative positioning nerve injuries. (Jan. 2005) Surgical Neurology. Accessed July 31, 2014.
- Sharma D. K., et al. Vascular injuries in total hip replacement arthroplasty: a review of the problem. (Oct. 2003). The American Journal of Orthopedics. Accessed July 31, 2014.
- Benedetti, Maria Grazia, et al. To what extent does leg length discrepancy impair motor activity in patients after total hip arthroplasty? (Dec. 2010). International Orthopaedics. Accessed July 31, 2014.
- Toshinori Masaoka, et al. Study of hip joint dislocation after total hip arthroplasty. (Sept. 2006). International Orthopedics. Accessed July 31, 2014.
- Butt, A. J. Sciatic nerve palsy secondary to postoperative haematoma in primary total hip replacement. (Nov. 2005). The Bone and Joint Journal. Accessed July 31, 2014.
- Stoltny, T., et al. Heterotopic ossification in patients after total hip replacement. (May-June 2007). Accessed on July 31, 2014.
- U.S. Food and Drug Administration. FDA executive summary memorandum: Metal-on-metal hip implant systems. (June 2012). Accessed January 20, 2014.
- DePuy Orthopaedics. https://www.depuysynthes.com/about/news-press/qs/depuy-orthopaedics-voluntarily-recalls-asr-hip-system---depuy (n.d.). Accessed Aug. 11, 2014.