Attune Knee System

  •  Hip & Knee Replacement Medical Record Review & Outsourcing Services

DePuy Synthes is one of the orthopedic franchise acquired by Johnson and Johnson in 1998 and is involved in manufacturing, designing, marketing products for repairing, reconstructing, correcting, treating various traumatic skeletal damages, bone fractures, and joint deformities.

DePuy Attune Knee System is one of the well-known products used for Total Knee Replacement Prosthesis of DePuy Synthes. Posterior Stabilized (PS) Femoral Component and PS Fixed Bearing Inserts are two parts of the Prosthesis, which was approved by the FDA using the 510k process. It was believed that the product was one of the largest development catering needs of patients, surgeons until gradually complaints started popping up.

Some instances like the loosening of implants and the entire knee becoming unstable were found which proved that the device is defectively designed. The only way to manage these failures was revision surgery which was painful and all the more troublesome to patients. The concern was later investigated and it became evident that the surface of these devices was very smooth so the surgical glue wasn't able to hold the joint in place.

Serious Alleged Injuries may include:

  • Premature loosening
  • Severe pain
  • Inflammation and swelling
  • Limited mobility
  • Infection
  • Bone, joint, muscle or neurological damage
  • Instability when standing or putting weight on the Implants

FDA Safety Warnings:

Hundreds of complaints were filed with the FDA against the implant. According to the FDA,  a small wire coil on the instruments, called a Balseal, could come off during surgery and fall into the wound which might remain in the patient’s body and remain unnoticed.

DePuy Attune Knee Recall:
2013: FDA warned DePuy for its diaphyseal sleeve, a part which was faulty and was recalled.
2015: DePuy recalled 3,474 defective surgical tools used in Attune knee surgery.

Legal Updates:

The first lawsuit was filed on September 2017 in the Circuit Court of Tuscaloosa County by Cunningham Bounds LLC which alleged that Johnson & Johnson and its subsidiary DePuy Synthes created a defective device. Multiple lawsuits are now getting filed against the manufacturers.

Evidence:

  • Usage of Attune Knee System
  • Detailed Operative reports
  • Implant Sticker and relevant details like Product Code, Manufacturer, Lot number
  • Follow-up complications and their treatment after Attune Knee System insertion

Medical Record Review and claim validation of Attune Knee System case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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