The Exactech Implant RecallsThere have actually been several stages of recalls over the past year or so as the extent of Exactech product defects has been realized to be more expansive than originally thought. The Florida-based medical device company first issued a recall for its Connexion GXL hip device in June 2021 when reports of premature wear arose that posed a health risk to those with the implant. Later in August of 2021. Exactech put out another recall but this time of its knee and ankle arthroplasty polyethylene inserts when reports came in regarding premature wear among these products as well. This recall did not include all inserts and only applied to certain labels and shelf-life parameters. The most recent recall came in February 2022 and expanded the previous recall to all of the Exactech knee and ankle arthroplasty polyethylene inserts. The Food and Drug Administration (FDA) has classified these as class 2 recalls that now affect about 150,000 medical devices distribute across the United States since 2004.
Why Are Exactech Implants Being Recalled?Even the slightest of defects can have catastrophic consequences when it comes to medical devices. The knee implants created by Exactech are no exception and are now being recalled not because of a defect of the implant itself but because of a packaging issue. This goes to show that there is no room for error when it comes to every step of manufacturing, designing, storing, etc. a medical device.
Exactech Knee Polyethylene Insert Packaging DefectsThe main issue with Exactech knee implants is that their polyethylene plastic insert components need to be stored in vacuum-sealed bags in order to prevent degradation due to oxidization. When the polyethylene inserts of these implants are exposed to oxygen during their storage their material can react to the air and oxidize which can lead to degradation. The oxygen diffuses into the plastic material of the insert and damages it so it wears out prematurely leading to health risks. The polyethylene inserts are but one component of Exactech's knee implants. These polyethylene inserts are placed between the femoral component that attaches to the thigh bone and the tibial tray that fits into the shin bone. They function as a cushion between these two components that make up the new knee joint which means durability is an important requirement; one that has been compromised by potential oxidization. Exactech has confirmed that most of their polyethylene inserts manufactured since 2004 were packaged in out-of-specification vacuum bags that were oxygen resistant but lacked a secondary barrier layer containing ethylene vinyl alcohol (EVOH) that provided a much-needed additional layer of oxygen resistance. As a result, many Exactech knee implants were compromised by premature wear and pose a risk to thousands of knee replacement recipients.
Exactech Connexion GXL Acetabular Polyethylene Hip Implant Liner DefectsIn addition to the defective knee implants, Exactech has also recalled their defective hip replacement implants that utilize Connexion GXL Polyethylene Acetabular Hip Liners. Similar to the knee implant inserts, the hip liners are also comprised of polyethylene plastic and are placed between two components that create a joint with the purpose of providing a cushion. Exactech has listed its reason for recalling these liners and the devices that use them as- “Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.” FDA recall reports indicate that there are almost 90,000 of these hip replacement parts in circulation.
Which Exactech Knee Implant Products Use These Recalled Components?The following are the components that have since been named as compromised by Exactech per their emergency letter to Exactech knee and ankle surgeons, hospitals, and health care professionals. If your knee replacement utilized one of these components then you could be at risk. To determine if your implant utilized these components, contact the surgeon that implanted your replacement hip or knee if they have not already contacted you about the risk posed by these recalled medical devices.
- Optetrak All-Polyethylene CR Tibial Components
- Optetrak All-Polyethylene PS Tibial Components
- Optetrak CR Tibial Inserts
- Optetrak 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
Which Exactech Hip Implant Products Use These Recalled Components?Any Exactech medical product that utilizes the Connexion GXL Acetabular Polyethylene Hip Implant Liner poses a risk to patients due to preemptive wear. The following systems have been identified as containing these compromised components and have been recalled.
- MCS Hip System
- Novation GXL
- Acumatch GXL
The Danger Posed by Degraded Exactech ImplantsGoing through the ordeal of having a hip or knee replaced is harrowing enough. Surgery and recovery are costly not to mention painful. The aforementioned Exactech components can potentially inflict serious damage to those that have had implants containing them due to their preemptive wear and tear. All joint implants have a point at which they wear out but preemptive wear caused by degraded polyethylene can cause the following:
- Accelerated wear debris production
- Bone loss
- The disintegration of bone cells (lysis)
- Loss of range of mobility
- Component fatigue cracking/fracture
- Necessary corrective revision surgery
Injuries Caused by Defective Exactech Knee and Hip DevicesIn addition to the myriad of uncomfortable symptoms that accompany the premature wear of Exactech knee and hip implants, there are also many serious health conditions that can develop. Aside from the obvious risk of muscle and bone tissue damage generated by faulty joint implants, there are also the following health issues that can arise.
Osteolysis of the BoneOsteolysis is when bone tissue is broken down and degenerates. This typically occurs when joint implants wear away and release plastic or metal particles that trigger the body's autoimmune response. Bone cells called osteoclasts break down the bone tissue that is reabsorbed by the blood as calcium and minerals. As one might expect, degeneration of bone tissue near the site of an implanted medical device, especially at a joint, can pose a serious problem. The implant can become loosened and threaten to cause further structural damage or the bone can end up breaking because of the loss of tissue.
Synovitis Caused by Joint Implant WearSynovitis is a medical condition that involves the synovial membrane that lines the joints becoming inflamed. There can be a significant amount of pain as well as swelling as well as a risk of joint degeneration if the condition persists. Synovitis symptoms include lumps, nodules, and swelling near the affected joint as well as joint pain and tenderness.
Revision of the Defective ImplantThe most common issue facing those with defective Exactech hip and knee implants is the need to have their knee or hip implant corrected via revision surgery. One might assume that having your defective knee or hip implant fixed is not much different from the initial surgery done to place the medical device in the first place. Unfortunately, this is not the case. Revision surgery is often longer and more complex than the procedure that placed the implant. The surgery that revises the issues with the defective hip or knee implant has to not only address the replacement of the worn-out components but also has to reopen a surgical site and address the damage done by the defective implant. This means carefully removing the components in a way that avoids further damage which involves removing the cement used to secure the implant as well as the tissue surrounding it. Naturally, this all comes with the risks that usually accompany surgery such as
- Surgical site infections
- Excessive bleeding
- Poor wound healing
- Anaesthesia complications
- Heart attack risk
- Permanent damage to tissue
Who Is at Risk for Exactech Knee and Hip Device Injuries?Anyone that has had a knee or hip implant put in with any of the aforementioned Exactech components that have been recalled should contact their doctor immediately if they have not already been contacted by them about the recall. If you are unsure about whether or not your implant has these components then contact the surgeon or facility responsible for the surgery that put in your implant. They should be able to provide you with a clear answer or at the very least, you should be able to get ahold of your records that should list your implant's information and serial number that you can look up on Exactech's website.
Exactech Knee or Hip Implant Failure Symptoms
- Knee or hip swelling
- Loosening of the joint
- Pain while walking
- Inability to bear weight
- Grinding or other noise at the implant site
- Clicking sensation in the implant
What Can I Do if I Have a Defective Exactech Hip or Knee Implant?When you consult with your doctor about your hip or knee implant they will perform medical imaging via x-ray or CT scan and other tests to determine the risk your implant poses as well as any damage it may have already inflicted. If they conclude that you should undergo revision surgery then you will likely be facing significant damages because of Exactech's mistakes. Exactech understands that many will seek to hold them accountable for the damage their defective medical devices have caused. This is why they have retained the services of a settlement adjustment company named Broadspire in order to handle claims those injured will and have filed against them.
Exactech's Proposed Settlement Coverage May Not Be SufficientWhile this gesture seems par for the course and a fair move on Exactech's part to take responsibility for their defective products, there are some things you will want to consider. Exactech only intends to cover claimants' out-of-pocket expenses and medical costs related to the evaluation and treatment of injuries inflicted by their recalled implants. In many cases, people that have been harmed by these implants will have damages that go beyond Exactech's narrow scope of proposed coverage. Exactech's assessment of the expenses they agree to pay may be undervalued as well. Remember that Exactech is not doing this out of the goodness of their hearts. You need to assume that Broadspire is acting in their best interest and not yours before you consider taking any settlement they might offer you. It is strongly recommended that you at least speak to a product liability attorney about your case before you approach Exactech with a claim. Otherwise, you could make the mistake of taking a settlement that you later realize does not fully cover your damages and you can lose the ability to seek the full value of your damages in the future.
What Damages Can I Claim in a Defective Defective Medical Device Lawsuit?In a product liability case, damages are the losses a claimant suffers as a result of an injury caused by a defective product. Damages inflicted by defective Exactech hip and knee implants can go far beyond medical expenses. Economic damages can encompass more than the treatment of your injuries and include lost wages or lost earning potential. Non-economic damages without a clear dollar value like pain and suffering can also be claimed as well. The following are some of the damages that can be compensated through an Exactech knee or hip implant recall settlement.
- Medical expenses
- Lost wages
- Lost earning potential
- Loss of enjoyment of life
- Pain and suffering