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FDA Issues Class I Recall on DePuy’s Limb Preservation System™ Lower Extremity Dovetail Intercalary Component

DePuy Orthopedic has voluntarily recalled the Limb Preservation System™ (LPS) Lower Extremity Dovetail Intercalary Component, which has been classified by the Food and Drug Administration (FDA) as a Class I Recall. Class I Recalls are the most serious type of recall and involve situations in which there is a reasonable probability that the use of such products will cause serious adverse health consequences or death.

The FDA reports that the product at issue – the Limb Preservation System™ (LPS) Lower Extremity Dovetail Intercalary Component – is intended for replacement of the mid-shaft portion of the femur, top, bottom and/or total femur, and top tibia, especially in cases that require extensive resection. The FDA further reports that the reason for the recall is that the “LPS™ Lower Extremity Dovetail Component has the potential for fracture of the female component, at the dovetail, when exposed to normal physiologic loads while walking. This may also lead to additional pain, infection, loss of function, loss of limb, neurovascular injury or need for revision surgery. Patients greater than 200 lbs. and/or those with high levels of activity are at higher risk of fracture.”

On July 11, 2013, DePuy issued an Urgent Medical Device Recall informing physicians and surgeons of the problem and to immediately stop distributing or using the recalled lots of products. The products at issue that are subject to the recall involve particular lots of LPS devices that were manufactured and distributed between February 2007 to May 2013. According to a recent report, a DePuy spokesperson said that 96 components were sold globally between these dates of February 2007 and May 2013. To date, the company has received seven complaints of fracture. The recalled LPS Lower Extremity Dovetail Intercalary Components include the following lot numbers: 130896, 132131, 132133, 209461, 209466, 219843, 232972, 295965, 310189, 336843, 349283, 352878, 374125, 379089, A1TAR1, A2AGN1, A2AGS1, A2AGT1, A2AGV1, B2VAL1, B43G11, B43G1A, B43G1B, B43G1C, B43G1D, B69HV1, B69HVA, BK1BB1, BW7DX1, BW7DX1A, E3SJD1, and EN4KJ1.

Another report provides that DePuy previously warned that the female component of the affected part – the lower extremity dovetail intercalary component – may break under abnormal force loads. However, the company now warns physicians and patients that the component has the potential to fail “when exposed to normal physiologic loads while walking.”

 

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