Depuy Corail Metal on Metal Hip Replacement System Lawsuit
DePuy Corail Hip Implant Failure
The DePuy Corail Hip Implant System may fail prematurely causing the patient crippling pain and the need for further revision surgery.
On August 19, 2010 the FDA issued a warning letter to DePuy Orthopaedics, Inc. president David Floyd ordering the company to halt marketing the Corail Hip System.
Depuy Corail Hip System Unapproved Uses
The FDA granted clearance for the Corail Hip System in 2009 for total hip arthroplasty in patients where there is evidence of sufficient sound bone to seat and support the components. However, according to the FDA warning letter, DePuy's brochure about the device lists a number of claims that were never approved by federal regulators. Total hip replacement was indicated in the following conditions:
A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.
The nonporous Corail is indicated for cementless use only.
However, the FDA says a brochure on DePuy's Web site promotes the use of the Corail for osseointegration, "a major change or modification in the intended use of your device that require a new premarket notification."
Read the FDA warning letter ::
Defective Hip Replacement Lawsuit
If you or a loved one have suffered or been injured from a defective DePuy Hip Implant or needed a hip implant revision you may be entitled to compensation. Contact the DePuy hip Implant attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding the DePuy Hip Implants, a possible DePuy Hip Implant class action lawsuit, or any other type of DePuy hip implant litigation.
DePuy Hip Implant Failure/Recall Lawsuit News Archive::