Stryker Hip Implant

  • Stryker Hip Implant Medical Record Review & Outsourcing Services

Stryker Orthopaedics is known for the development and manufacture of specialty surgical products and other medical supplies for health care around the world. The company has manufactured scores of medical devices and joint replacement products, most of which have been successful; however, some of the hip replacement devices have caused serious adverse events, injuring hundreds of patients.

The Stryker Rejuvenate Modular-Neck Stem and the ABG Modular-Neck Stem hip replacement devices were approved by the Food and Drug Administration (FDA) in 2008 and 2009. These devices are not typical "metal-on-metal" (MoM) as the necks are built of Cobalt and Chromium and the neck stems are layered with Titanium. Though the intention was to make it corrosion resistant, the two metals rubbed on each other at the connection and released toxic metal ions and debris. Stryker permanently recalled the Rejuvenate Modular and ABG II Modular-Neck Hip Stems in 2012 and stopped all global sales and production of these components. Another hip stem model, the Accolade TMZF, also caused problems and was recalled in 2009, 2011, and 2013.

Most patients with Stryker Rejuvenate and ABG II implants have undergone additional surgery or revision surgeries to remove and replace the implant to repair or reconstruct injured joints, bones, and tissues in addition to the replacement surgery.   

Serious Alleged Injuries may include:

  • Metallosis (the build-up of metal ions in the body)
  • Inflammation and swelling
  • Limited mobility
  • Bone, joint, muscle or neurological damage
  • Necrosis-tissue and bone death due to metallosis toxicity
  • Popping, crunching or other noises from the hip caused by movement
  • Fractures of one or more components

FDA SAFETY WARNINGS:

Hundreds of adverse event reports were received by the FDA in 2012 involving the implants. This was followed by a voluntary recall by the manufacturer and then by the release of safety warnings by the FDA.

Lawsuit Allegations:

Hip recipients who were injured by Stryker's Rejuvenate and ABG II neck and stem implants filed lawsuits against Stryker Orthopaedics. Suits allege that Stryker designed faulty devices, failed to adequately test them in humans before marketing, failed to warn the public and medical community, and concealed information about the risks of adverse events caused by the devices.

In November 2014, Stryker agreed to settle several thousands of claims for $1.4 billion. This settlement encompassed cases in the New Jersey MCL and the Minnesota MDL and all the claimants who had revision surgery before Nov. 3, 2014. On the same lines, compensations were to be provided to patients operated before Dec 19, 2016.

Lawsuits nearing 5,000 had been filed concerning both Stryker hip models since the 2012 recall. Two litigations had been set up due to the high number of claims: the multidistrict litigation (MDL 2441 before Judge Donovan W. Frank) in the U.S. District Court in the District of Minnesota, and a state-level multi-county litigation (MCL) before Judge Brian R. Martinotti in Bergen County, New Jersey (NJ).

In November 2014, Stryker agreed to settle several thousand claims for $1.4 billion. This settlement encompassed the New Jersey MCL and the Minnesota MDL cases, and for all claimants who had revision surgery before Nov. 3, 2014. Stryker Hip recall settlement values were announced at up to $300K per hip. It was reached after four months of negotiations with Stryker mediated by retired U.S. Magistrate Judge Diane Welsh and had no cap on the fund. On the same lines, compensation was provided to patients operated before Dec. 19, 2016.

In April 2017, MDL No. 2768 (In re Stryker LFIT V40 Femoral Head Products Liability Litigation) was formed to be presided by U.S. District Judge Indira Talwani in the United States District Court for the District of Massachusetts. The first bellwether is to commence on September 16, 2019.

Evidences:

  • Indication of Usage in Medical and Pharmacy Records
  • Implant Sticker and relevant details like Product Code, Manufacturer, Lot number
  • Follow up complications and their treatment after Stryker hip implant insertion
  • Revision surgeries and implants

Medical Record Review and claim validation of Stryker Hip Implant 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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