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Published: February 25th, 2013
Due to problems with the DePuy LPS Diaphyseal Sleeve, a component used in the Limb Preservation System knee replacement system during reconstructive knee surgery, a recall was issued in early 2013.
It has been reported that patients face an increased risk of the DePuy LPS knee fracturing and loosening, which could result in loss of the leg, dangerous infections or even death.
DEPUY KNEE LAWSUIT STATUS: Potential claims are being reviewed by DePuy knee replacement lawyers for individuals who have experienced problems after receiving the Limb Preservation System (LPS) and the LPS Diaphyseal Sleeve, including:
- Fracture of the Sleeve at the Taper Joint
- Loosening of the Knee Replacement
- Loss of Function of the Limb
KNEE COMPONENT: DePuy LPS Diaphyseal Sleeve distributed between 2008 and July 20, 2012 by DePuy Orthopaedics, a subsisidiary of Johns & Johnson.
OVERVIEW: The Diaphyseal Sleeve was used to make sure the other components of the DePuy LPS knee system fit together properly. The DePuy LPS knee replacement is used to reconstruct severe defects in soft tissue and bone.
On January 4, 2013, DePuy Orthopaedics, a subsidiary of Johnson & Johnson, sent an urgent recall notice to health care providers, warning them to stop using the sleeve on their patients due to a risk of fracturing.
On February 22, the FDA determined that the action constitutes a Class I medical device recall for the LPS Diaphyseal Sleeve, which is the most severe type of medical device recall, suggesting that the agency believes continued use of the product poses a substantial risk of severe adverse health problems or death. The agency indicated that the DePuy knee implant could fracture or fail, increasing the risk of limb loss, infection, compromised soft tissue, and even death.
REPORTS OF DEPUY LPS KNEE FRACTURING AND LOOSENING: At the time of the recall, the FDA had received at east 10 reports of incidents involving the LPS Diaphyseal Sleeve knee implant. In six cases, the device fractured, and in four cases loosening was reported. However, the number of reported adverse events typically only represent about 1% to 10% of all problems associated with approved medical devices.
The FDA believes that the taper connection between the LPS Diaphyseal Sleeve and the Sleeve Base may not be able to handle the loads placed on it during normal walking.
As a result of the recalled DePuy knee implant, patients may have been exposed to an increased risk of leg amputation, infection, and death. Financial compensation may be an option through a DePuy LPS knee lawsuit as a result of the manufacturer’s failure to adequately evaluate the risks associated with the implant or warn about the risk of DePuy LPS knee problems.