FDA Recalls of DePuy Attune Knee Replacement System

DePuy Knee Lawsuit News

Depuy has been hit with several recalls of its Attune knee replacement system

Friday, April 27, 2018 - The knee is the largest joint in the body and is expected to carry the full weight of an individual with every step. Failing to perform properly, faulty artificial knees put the health and safety of millions of individuals at risk.

Scrutinization of the companies profiting from the multi-billion dollar knee replacement market is of paramount importance for the U.S. Food and Drug Administration which has issued recalls of thousands of DePuy knee replacement systems in recent years.

DePuy Synthes, the medical devices unit of Johnson & Johnson, was forced in June of 2015 to issue a worldwide voluntary recall of several of the component parts of its Attune knee replacement system by the U.S. Food and Drug Administration for failing to receive prior FDA approval. In a warning letter to the company, the FDA found that not only had the components not received approval but also that the components had been altered and were no longer safe. Medical device components often escape the required FDA approval process when the device replicates another that has already received approval.

The component part of the Attune knee implant in question is a small wire spring called the "Balseal" that has been found to detach and become embedded in the tissues surrounding the artificial knee. The FDA describes that the intended use of the Balseal as follows: "The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components. The FDA's reason for the recall is given as, "Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trailing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left within the patient if the surgeon is unaware of the disassociation." The recall affected 3475 units of the Attune knee replacement device.

Patient complaints registered as adverse events with the FDA prompted the agency to investigate the Balseal component. DePuy knee recipients have reported wobbliness, looseness, instability, abnormal warmth, unexplainable swelling and severe pain. Scar tissue forming around the dislodged component may cause scarring, nerve damage and decreased range of motion, as well as clicking sounds or grinding. Infections from metal and plastic shavings caused by the Baleal remaining around the artificial knee can also result. Tibial fractures due to misalignment of the lower and upper leg were also reported. Revision surgery was required to repair or replace the artificial knee.

In 2013, prior to the Balseal component recall, Depuy was forced in a letter from the FDA to issue a recall of the LPS Limb Preservation System's LPS Diaphyseal Sleeve used to reconstruct soft tissue and bone. The LPS Diaphyseal Sleeve is a support insert in the soft bone tissue and failed to provide sufficient load-bearing support. Patients reported leg bone fractures and infections. In their no punches pulled warning, the FDA stated that the LPS System could lead to the "loss of limb, infection, compromised soft tissue and death." DePuy knee lawsuits are not class action lawsuits in which those who file a claim can expect only a small, symbolic settlement.

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Onder, Shelton, O'Leary & Peterson, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. Onder, Shelton, O'Leary & Peterson has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others. The Onder Law Firm won $197 million in three talcum powder ovarian cancer lawsuits in St. Louis in 2016 and other law firms throughout the nation often seek its experience and expertise on complex litigation.