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Exactech Knee & Hip Replacement Lawsuit & Recall 2022

Last Updated: December 1, 2022

Exactech, a global company that specializes in orthopedic implants for joint replacements, has been forced to recall thousands of knee, hip, and ankle inserts after they have been found to be potentially defective. The company issued the recall – covering a huge number of implants manufactured and sold since 2004 – after it was discovered that faulty packaging had a detrimental effect on a polyethylene insert, causing them to degrade prematurely. The upshot is that thousands of people who have had Exactech implants may require corrective surgery. Those who had implants may be eligible to join the Exactech implant lawsuits, some of which have already been consolidated into an MDL (multidistrict litigation). Exactech knee replacement lawsuit lawyers are asking for more people to come forward to join the litigation, believing that those with defective implants should be compensated.

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Exactech Knee & Hip Replacement Lawsuit News & Updates

  • December 1, 2022 - Exactech Recall information Update.

The most important news about the Exactech lawsuits came in the fall of 2022 when courts in Florida and New York agreed to consolidate individual Exactech knee and hip replacement lawsuits into MDLs. This was an important step for the litigation, as an MDL both acknowledges and anticipates large numbers of claimants joining the lawsuits. The consolidation of the lawsuits comes after the series of Exactech recalls over the summer of 2022, which saw the company have to expand the scope of the product recall after more evidence came to light. We now know that the recall covers almost 20 years of knee, hip, and ankle implants, meaning 1000s of Americans may require surgeries – that they previously believed were unnecessary – to correct the problems with the implants. These surgeries will, of course, carry injury risks, and those impacted may also lose out financially due to medical bills, loss of earnings, etc. Lawyers believe that compensation is due, and they have accused Exactech of being negligent in manufacturing and selling these potentially dangerous implant products.

Exactech Lawsuit

Exactech Recall 2022

The Exactech recalls first came to mainstream attention in June 2021. The company sounded the alarm with “Urgent Medical Device Correction” letters for Exactech Connexion replacement inserts on June 28th, which was later backed by the FDA. The FDA published this as a Class 2 Recall, meaning the equipment posed an injury risk but that it could be reversed; by corrective surgery in this case. As mentioned above, the scope of the Exactech FDA Recalls had to be widened in the 12 months that followed, leading to an update of the Exactech knee and hip implant recall in August 2022. News of the recalls has prompted those affected to file lawsuits against the medical implants company.

Exactech manufactures a range of medical devices, but the company specializes in replacement implants. Below we list some of the replacement procedures impacted by the recall:

Exactech Knee Replacement Recall

Exactech knee replacement inserts are covered by the recall issued by the company and backed by the FDA.

Exactech Hip Replacement Recall

Exactech hip replacement inserts are covered by the recall issued by the company and backed by the FDA.

Exactech Ankle Replacement Recall

Exactech ankle replacement inserts are covered by the recall issued by the company and backed by the FDA.

FDA Exactech Recall

It’s important to point out that the Exactech problems surround the packaging of its knee, ankle, and hip replacement systems. Essentially, there was a defect in the vacuum seal, causing the replacement system to oxidize before use. Consequently, the replacement insert in the ankle, knee, and hip would degrade quicker than the norm. The FDA was alerted to the problem by Exactech in the summer of 2021, backing the company’s recall and warning those who have Exactech implants that they may experience pain and mobility issues due to the faulty replacements. Anyone who has had a hip, knee, or ankle replacement will be aware that the implant can degrade over time due to wear and tear, but the defect in the Exactech defective packaging seems to have acted as a catalyst for the degradation of the inserts.

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Exactech Knee & Hip Replacement Side Effects & Injuries

Harvard Medical School estimates that the average knee or hip replacement has a lifespan of 10-15 years. After that, corrective surgery or a further replacement may be needed. There are various reasons for this lifespan, but most are linked to the degradation of the insert due to wear and tear. The Exactech lawsuits are focused on the fact that Exactech implants might have a defect that reduces this lifespan significantly, leading to painful side effects in those who have had knee and hip replacements. Some of the Exactech side effects may include:

  • Swelling of the joints – hip, ankle, knee – around the insert.
  • Loss of balance, difficulty walking, instability.
  • Chronic pain, and stiffness.
  • Grinding and clicking of joint area while moving.
  • Problems bearing weight on joint area.

While all of these Exactech side effects can cause pain and suffering, perhaps the most worrying thing for those affected by the situation is that they may require further corrective surgeries. As we have said, these are complicated and dangerous procedures. Moreover, even if the additional surgery is deemed a success, it can still lead to further issues and leave people out of pocket. It’s for that reason that Exactech hip and knee replacement lawyers are aiming to secure significant compensation for claimants who have had defective replacements.

Exactech Side Effects Injuries

Knee & Hip Replacement Risks

It goes without saying that there can be many complications with knee and hip replacement procedures. It requires major surgery, and patients are acutely aware that both the procedure and the implant can have long-term consequences and side effects. Some of the risks of knee, hip, and ankle replacement surgeries include:

  • Infection, including infection of surgical wound.
  • Improper healing of wounds.
  • Excessive bleeding, clotting.
  • Anesthesia complications.
  • Nerve damage, bone fractures, bone loss.
  • Risk of heart attack, blood vessel damage, or lung damage.

The above list is not exhaustive, and we know that knee and hip replacements can carry risks inherent in all types of surgeries.

Exactech Cases

Who are the people bringing legal cases against Exactech? While Exactech is headquartered in Gainsville, Florida, and many of the lawsuits have been filed in the Sunshine State, the Exactech case is a nationwide litigation. Thousands of people have had Exactech knee, ankle, and hip replacements, and we now know that the defective packaging problem potentially stretches back 18 years. Cases are being brought forward by lawyers representing Exactech replacement patients who have experienced difficulties, including pain and mobility issues, and who may require corrective surgeries.

Exactech Litigation

Exactech litigation has moved forward in states all around the country. As highlighted earlier, many of these cases have been concentrated in Florida and, to a lesser degree, New York. However, Exactech lawsuit eligibility extends to people who have been affected in all 50 states. While we know some specific details as set out by the Exactech FDA recalls, we are still learning how and when this might have impacted people. As such, there is a consensus that more people will come forward to join the litigation against Exactech, providing further evidence that the company sold defective products that have caused pain and suffering among those who entrusted it with their care.

Exactech Recall Lawyer

If you believe you have a claim against Exactech after a hip, knee, or ankle replacement, then you will require the services of an experienced personal injury lawyer. Right now, specialist Exactech injury lawyers have asked for more people to come forward to file for compensation. Exactech has admitted some level of fault by recalling its products nationwide, so you should contact an Exactech recall law firm if you believe you have been impacted.

Is Exactech Lawsuit a Class Action Lawsuit or a Mass Tort Lawsuit?

Right now, we are in a period of consolidation for the Exactech lawsuits. This means that judges are deciding the best way for the litigation to proceed. In Florida and New York, cases have already been consolidated into MDLs (multidistrict litigation). An MDL is a type of mass tort lawsuit, which differs from a class action lawsuit. In an MDL, the cases and judgments are combined together for reasons of expediency, but each claimant is accounted for independently. This is important in cases like the Exactech lawsuit, as the level of injury caused – and compensation awarded – will be different for each claimant. In a class action lawsuit, the litigation usually covers people with identical grievances, and the outcome usually sees all claimants share an equal portion of the settlement.

Exactech Lawsuit FAQ

What Is Exactech?

Exactech is a medical device company specializing in surgical replacement inserts, i.e., the devices used to replace a hip, knee, ankle, or other joints in surgery.

What is Exactech recall?

The Exactech recalls occurred throughout 2021 and 2022 when the company warned that its products put patient safety at risk due to a defect in the packaging. In the simplest terms, the packaging defect means that the replacement parts could degrade quicker than the norm, meaning patients may face undue pain and side effects, and they may require corrective surgery.

How do I know if my knee replacement is recalled?

You should check with your healthcare provider, implant manufacturer, or the FDA website for further information on your particular knee replacement.

When Did Exactech Lawsuit Start?

The lawsuit against Exactech began almost immediately after the Exactech recall of 2021. Cases have been filed around the country, and many more people are expected to join the Exactech lawsuits in 2022 and beyond.

Who owns Exactech Inc?
Exactech was previously a public company, but it was taken private in 2018 after a successful takeover bid by TPG Capital, a private equity firm.

What brand of hip replacement is being recalled?

Exactech hip replacement inserts are being recalled, alongside recalls for its ankle and knee inserts.

What is the most commonly reported problem after knee replacement surgery?

Most patients and surgeons fear the risk of infection after surgery. However, there are many other complications that can occur.

What does a loose knee replacement feel like?

Loose knee replacement symptoms can manifest themselves in many different ways, including pain, lack of balance, clicking, and swelling. If you are concerned, you should contact your healthcare provider.

Exactech Product List Recall 2022

Product LineSpecific Brand NameTotal Units Sold
Globally
(2004-2.22.2022)
OPTETRAK® All-polyethylene Tibial Components (TKR) 5078
200-11-XXOPTETRAK® All-polyethylene CR Tibial Components1
200-12-XXOPTETRAK® All-polyethylene CR Tibial Components36
200-13-XXOPTETRAK® All-polyethylene CR Tibial Components117
200-14-XXOPTETRAK® All-polyethylene CR Tibial Components79
200-15-XXOPTETRAK® All-polyethylene CR Tibial Components38
200-16-XXOPTETRAK® All-polyethylene CR Tibial Components8
204-11-XXOPTETRAK® All-polyethylene PS Tibial Components1097
204-12-XXOPTETRAK® All-polyethylene PS Tibial Components1834
204-13-XXOPTETRAK® All-polyethylene PS Tibial Components1277
204-14-XXOPTETRAK® All-polyethylene PS Tibial Components528
204-15-XXOPTETRAK® All-polyethylene PS Tibial Components61
204-16-XXOPTETRAK® All-polyethylene PS Tibial Components2
OPTETRAK® All-polyethylene Tibial Components (PKR) 3428
252-12-XXOPTETRAK® All-polyethylene UNI Tibial Components1163
252-13-XXOPTETRAK® All-polyethylene UNI Tibial Components1198
252-22-XXOPTETRAK® All-polyethylene UNI Tibial Components524
252-23-XXOPTETRAK® All-polyethylene UNI Tibial Components543
OPTETRAK® Tibial Inserts (TKR) 218944
200-21-XXOPTETRAK® CR TIBIAL INSERT5803
200-22-XXOPTETRAK® CR TIBIAL INSERT24356
200-23-XXOPTETRAK® CR TIBIAL INSERT20527
200-24-XXOPTETRAK® CR TIBIAL INSERT9570
200-25-XXOPTETRAK® CR TIBIAL INSERT3032
200-26-XXOPTETRAK® CR TIBIAL INSERT270
200-50-XXOPTETRAK® CR TIBIAL INSERT161
200-51-XXOPTETRAK® CR TIBIAL INSERT4102
200-56-XXOPTETRAK® CR TIBIAL SLOPE + INSERT67
200-57-XXOPTETRAK® CR TIBIAL SLOPE ++ INSERT93
200-61-XXOPTETRAK® CR TIBIAL SLOPE + INSERT176
200-62-XXOPTETRAK® CR TIBIAL SLOPE + INSERT1012
200-63-XXOPTETRAK® CR TIBIAL SLOPE + INSERT1047
200-64-XXOPTETRAK® CR TIBIAL SLOPE + INSERT623
200-65-XXOPTETRAK® CR TIBIAL SLOPE + INSERT204
200-71-XXOPTETRAK® CR TIBIAL SLOPE ++ INSERT148
200-72-XXOPTETRAK® CR TIBIAL SLOPE ++ INSERT906
200-73-XXOPTETRAK® CR TIBIAL SLOPE ++ INSERT1030
200-74-XXOPTETRAK® CR TIBIAL SLOPE ++ INSERT563
200-75-XXOPTETRAK® CR TIBIAL SLOPE ++ INSERT218
204-21-XXOPTETRAK® PS TIBIAL INSERTS10048
204-22-XXOPTETRAK® PS TIBIAL INSERTS38886
204-23-XXOPTETRAK® PS TIBIAL INSERTS32689
204-24-XXOPTETRAK® PS TIBIAL INSERTS14623
204-25-XXOPTETRAK® PS TIBIAL INSERTS4748
204-26-XXOPTETRAK® PS TIBIAL INSERTS611
204-50-XXOPTETRAK® PS TIBIAL INSERTS392
204-51-XXOPTETRAK® PS TIBIAL INSERTS5516
204-91-XXOPTETRAK "MOMB" NON-MOD MOLDED INSERT282
204-92-XXOPTETRAK "MOMB" NON-MOD MOLDED INSERT864
204-93-XXOPTETRAK "MOMB" NON-MOD MOLDED INSERT1167
204-94-XXOPTETRAK "MOMB" NON-MOD MOLDED INSERT668
204-95-XXOPTETRAK "MOMB" NON-MOD MOLDED INSERT176
208-21-XXOPTETRAK® CC TIBIAL INSERT2996
208-22-XXOPTETRAK® CC TIBIAL INSERT10026
208-23-XXOPTETRAK® CC TIBIAL INSERT9143
208-24-XXOPTETRAK® CC TIBIAL INSERT5175
208-25-XXOPTETRAK® CC TIBIAL INSERT1824
208-51-XXOPTETRAK® CC TIBIAL INSERT1136
224-21-XXOPTETRAK® B-SERIES PS TIBIAL INSERT547
224-22-XXOPTETRAK® B-SERIES PS TIBIAL INSERT1719
224-23-XXOPTETRAK® B-SERIES PS TIBIAL INSERT1347
224-24-XXOPTETRAK® B-SERIES PS TIBIAL INSERT453
OPTETRAK® HI-FLEX® Polyethylene Tibial Inserts (TKR) 51913
244-20-XXOPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts226
244-21-XXOPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts6787
244-22-XXOPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts18921
244-23-XXOPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts15578
244-24-XXOPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts7662
244-25-XXOPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts2739
ARTHROFOCUS® Polyethylene Tibial Inserts (TKR) 12
256-12-XXARTHROFOCUS® Polyethylene Tibial Inserts6
256-13-XXARTHROFOCUS® Polyethylene Tibial Inserts6
OPTETRAK® Custom Polyethylene Tibial Inserts (TKR) 41
900-06-XXCUSTOM OPTETRAK® ANGLED PS INSERT6
900-08-XXCUSTOM OPTETRAK® ANGLED PS INSERT6
900-23-XXCUSTOM OPTETRAK® CC TIBIAL INSERT21
900-30-XXCUSTOM OPTETRAK® CC TIBIAL INSERT4
900-33-XXCUSTOM OPTETRAK® CC INSERT4
OPTETRAK® LOGIC® Polyethylene Tibial Inserts (TKR) 127998
02-012-35-XXXXOPTETRAK® Logic PS Tibial Inserts80506
02-012-44-XXXXOPTETRAK® Logic PSC Tibial Inserts19323
02-012-47-XXXXOPTETRAK® Logic CR Tibial Inserts9139
02-012-48-XXXXOPTETRAK® Logic CR Slope + Tibial Inserts3083
02-012-49-XXXXOPTETRAK® Logic CR Slope ++ Tibial Inserts2853
02-012-51-XXXXOPTETRAK® Logic CRC Tibial Inserts10291
02-012-65-XXXXOPTETRAK® Logic CC Tibial Inserts2803
OPTETRAK® RBK® Polyethylene Tibial Inserts (TKR) 33393
264-21-XXOPTETRAK® RBK PS Tibial Components2938
264-22-XXOPTETRAK® RBK PS Tibial Components10994
264-23-XXOPTETRAK® RBK PS Tibial Components11560
264-24-XXOPTETRAK® RBK PS Tibial Components5738
264-25-XXOPTETRAK® RBK PS Tibial Components2163
TRULIANT® Tibial Inserts (TKR) 38075
02-022-35-XXXXTRULIANT® PS Tibial Inserts20913
02-022-44-XXXXTRULIANT® PSC Tibial Inserts6519
02-022-47-XXXXTRULIANT® CR Tibial Inserts3095
02-022-48-XXXXTRULIANT® CR Slope + Tibial Inserts504
02-022-49-XXXXTRULIANT® CR Slope ++ Tibial Inserts335
02-022-51-XXXXTRULIANT® CRC Tibial Inserts6709
OPTETRAK® Logic RBK Tibial Components (TKR) 10616
02-012-38-XXXXOPTETRAK® Logic RBK PS Tibial Components10616
Vantage® Fixed-Bearing Polyethylene Liner Component (TAR) 2959
350-21-XXVantage® Fixed-Bearing Polyethylene Liner Component1422
350-22-XXVantage® Fixed-Bearing Polyethylene Liner Component1537
Vantage® Mobile-Bearing Polyethylene Liner Component (TAR) 761
350-41-XXVantage® Mobile-Bearing Polyethylene Liner Component352
350-42-XXVantage® Mobile-Bearing Polyethylene Liner Component409

Source: Exac.com

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We are here to help you and loved ones advocate for justice. Feel free to send us any questions you might have, either about an injury or the process for pursuing justice so we can help you exercise your rights.

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