—#114766

Product

LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.

FDA product code: MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K071417
Affected lot / code info: Part number: 198720028 and Lot numbers: 123510, 156211, 212355, B34GG1000, B4TH51000, B5RAX1000, B5RAXA000, B5RAXB000, CC3KX1000, CC3KXA000, E4RF31000, E4RF3A000, E55HV1, and EN4KN1000.

Why it was recalled

DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. 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.

Root cause (FDA determination)

Device Design

Action the firm took

DePuy Othopaedics sent an Urgent Information Medical Device Recall Notice letter dated January 4, 2013 to all affected customers. The letter identified the affected products, reason for recall, clinical implications and actions to be taken. The letter instructed customers to check inventory, discontinue use, cease further distribution and return all inventory on hand for credit. Customers were requested to complete and return the Reconciliation Form. For product-related questions contact your local DePuy Othopaedics Sales Representative, clinical questions contact DePuy's Scientific Information Office at 1-888-554-2482 and recall notice information call 574-372-7333.

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, FL, GA, ID, IL, MA, MD, MI, MN, NC, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV and the countries of Holland, Australia, Austria, South Africa and Canada including Veteran Administration hospitals.

Timeline

Recall initiated: 2013-01-04
Posted by FDA: 2013-02-15
Terminated: 2014-05-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114766. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.