Hip, Knee, and Ankle Replacement Recall
Hip pain can be common, especially as we age. Arthritis, or injury to the hip can cause cartilage to decrease and break down over time. Cartilage helps the bone joints move smoothly and when it’s damaged, joints are exposed and unprotected. This can be very painful, making it difficult for most to be able to do the most basic daily activities. Walking without assistance, taking the stairs, getting dressed by yourself, or even getting up after sitting down can be grueling. When pain begins to interfere with daily activities, corrective surgery may be in order. When it comes to chronic hip pain, total hip replacements are recommended.
Total hip replacements are one of the most common orthopedic procedures performed today. Many hip replacement procedures successfully treat pain from arthritis, correct hip fractures, improve mobility, and lead to an overall better quality of life for the patient.
Since the late 1800s, scientists and researchers have experimented with different materials for hip replacement surgery such as ivory and glass. Modern hip replacements use three components: a stainless-steel femoral head, a polyethylene acetabular socket and acrylic bone cement. During a complete hip replacement, a hip liner is inserted into the leg. This device, which can be ceramic, metal, or plastic allows the new hip components to rotate and move freely. It is this component, made of ultra-high molecular weight polyethylene that is under recall by the FDA due to premature wear.
In June 2021, Exactech recalled its Connexion GXL acetabular polyethylene liner used in hip implants. The Class 2 device recall states there is a “Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.” However, studies have concluded that that there is a general link between the Connexion GXL liner and catastrophic early polyethylene wear.
A study published in May 2020 in the Journal of Arthroplasty titled “Early Polyethylene Failure in a Modern Total Hip Prosthesis: A Note of Caution” investigated patients from 2009 to 2019 who received a total hip replacement with the polyethylene liner. Seventy-five percent of those patients had to undergo corrective surgery; all of them suffering from osteolysis, which is a condition in which the bone tissue degrades over time and is eventually destroyed.
An additional study, published in Arthroplasty Today reviewed five cases of catastrophic early polyethylene wear who had total hip replacement surgery using the Exactech Connexion GXL liner. These patients all reported hip pain a few years after their surgery. Radiographs showed linear wear with acetabular and/or femoral osteolysis. The study concluded that there was a concerning trend with the Exactech Connexion GXL and further investigation was warranted.
Hip replacements today are common and can last for decades. In fact, over 50 percent of hip replacements done today last over 25 years. While hip replacements can wear out overtime, a hip replacement lasting under 10 years is abnormal. The average time the Exactech Connexion GXL lasts is approximately 55 months – just under five years.
The Dangers of Premature Wear
Patients with premature wear of the Exactech Connexion GXL may experience
- Limited Mobility
- Loose Hip Joints
- Osteolysis (bone loss)
Patients experiencing any of these symptoms may need revision surgery, which can be complex, expensive, and often not covered by insurance. These additional surgeries to repair or even replace the hip could compromise soft tissue and surrounding bone.
Who is Most at Risk?
Those most likely at risk are those who had total hip replacement surgery. Candidates for total hip replacement surgery are those who suffer from osteoarthritis, rheumatoid arthritis, osteonecrosis or may have an injury. During a total hip replacement surgery, damaged bone and cartilage is removed from acetabulum, which is a cup-shaped hollow in the pelvic bone, also known as the hip socket. An acetabular component, which is has an outer metal portion and an inner plastic portion is then inserted into the hip socket. Once the new hip socket is in place, a metal stem is inserted into the thighbone and a new ball for the joint. The now new socket contains a liner, which is typically made of plastic, moves like a regular joint does, allowing for weight to be put on the joints and for mobility to return. Many people who have hip replacement surgery go on to resume their normal lives and activities such has hiking, biking, and swimming.
Exactech Knee and Ankle Replacements also Recalled
In February 2022, a letter from Exactech informed surgeons and patients about complications found with their total knee replacements (TKR) and total ankle replacements (TAR) with polyethylene components. The devices were packaged in a way that did not prevent oxygen from diffusing into the plastic insert before it was inserted into the knee or ankle. If the device oxidizes, the plastic can wear down or become damaged after inserted into the patient. Excessive polyethylene wear can lead to device failure, pain, swelling, and osteolysis (bone loss).
List of recalled products:
The following implants have been recalled by Exactech:
Connexion GXL Acetabular Liner
OPTETRAK® All-polyethylene CR Tibial Components
OPTETRAK® All-polyethylene PS Tibial Components
OPTETRAK® CR Tibial InsertsOPTETRAK® CR Slope Tibial Inserts
OPTETRAK® PS Tibial Inserts
OPTETRAK® HI-FLEX® PS Tibial Inserts
OPTETRAK Logic® CR Tibial Inserts
OPTETRAK Logic® CR Slope Tibial Inserts
OPTETRAK Logic® CRC Tibial Inserts
OPTETRAK Logic® PS Tibial Inserts
OPTETRAK Logic® PSC Tibial Inserts
OPTETRAK Logic® CC Tibial Inserts
TRULIANT® CR Tibial Inserts
TRULIANT® CR Slope Tibial Inserts
TRULIANT® CRC Tibial Inserts
TRULIANT® PS Tibial Inserts
TRULIANT® PSC Tibial Inserts
VANTAGE® Fixed-Bearing Liner Component
Dangerous and Defective Medical Device Attorney
If you received a recent hip, knee, or ankle replacement and are experiencing new or worsening pain, swelling, joint clicking, limited mobility, instability or are unable to bear weight, contact your physician immediately to determine if your implant device was affected by the recall. Those affected by the recall may be able to recover damages including pain and suffering, lost wages, and other related medical expenses.
Goldberg, Persky & White, P.C. have represented thousands who have suffered injuries through faulty medical devices. We can answer your questions about the legal rights and remedies available to you. There is never an obligation, and our initial consultations are always offered free of charge. Call 1-800-471-3980 or contact us today by filling out our contact form.