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Wednesday, February 27, 2013

Knee Replacement Medical Device Recalled

The US Food and Drug Administration  (FDA) has notified healthcare professionals of a Class I recall of the LPS Diaphyseal Sleeve, a manufactured medical device used in human knee replacement surgery.
It has been found that The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients. This may result in fracture of the sleeve at the taper joint which may also lead to loss of function or loss of limb, infection, compromised soft tissue or death.
The device was manufactured by: DePuy Orthopaedic, Inc, a company owned by Johnson and Johnson.
The FDA has received a total of 10 reports (6 fractures and 4 reports of loosening that may or may not be attributed to the same device design issue) of incidents in which the device has malfunctioned.
The affected devices were manufactured from 2008 to July 20, 2012. 
Product Codes and Lot Numbers of the Recalled Devices:
Part #Lot #

The LPS Diaphyseal Sleeve is intended for use with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with femoral and tibial replacements.
On Jan. 4, 2013, DePuy issued an Urgent Medical Device Recall informing hospitals and surgeons of the problem and to immediately stop distributing or using the recalled lots. If a medical facility has the affected product in stock, it is being advised to return it to DePuy.
DePuy is not recommending revision or additional follow up in the absence of symptoms of patients with this implanted device. However, DePuy is encouraging surgeons to communicate with patients who received these implants and discuss the risks of the implant fracture and the method for detecting implant failure if the patient begins experiencing symptoms.

Read more about DePuy and workers' compensation
Dec 17, 2010
With an estimated 93,000 DePuy recalled artificial hips implanted worldwide, the workers' compensation benefit system will probably be paying for a vast amount of the remediation and treatment costs, and then having its ...
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DePuy release a statement today that they two products being recalled were: the ASR XL Acetabular System, a hip socket used in traditional hip replacement, and the ASR Hip Resurfacing System, a partial hip replacement ...
Jan 17, 2013
Johnson and Johnson has recalled 2 Hip Implants because of failure. The two implants were made by the DePuy Orthopaedics unit of Johnson and Johnson. The decision to withdrawn the products was based upon the fact .