Device 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.
Z-0829-2013
Product summary
- Event
- Event 63783
- Status
- Terminated
- Classification
- Class I
- Quantity
- 162 total units (US) and 102 units total (OUS)
- Official record key
device-enforcement:Z-0829-2013
Official wording
Reason: 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.
Code information: Part number: 198720020 and Lot numbers: 140576, 156212, 156213, 156214, 162644, 188411, 202954, 156214A, 202954A, B34GD1000, B4SBN1000, B4SBNA000, B4SBNB000, B4SBNC000, B5RAW1000, B5RAWA000, C3RHJ1000, C74JX1000, C74JXA, E18N61000, E3PKV1000, EF8GB1000, and FL2WB1.
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.
Derived failure modes
-
Unknown
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.