The Recall Desk
SevereFDA (Devices)·Z-1915-2012·Announced 2012-07-11

DePuy Recalls Luster and Ultima Hip Stems Implanted with Metal-on-Metal

DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima hip stems implanted with metal-on-metal articulations.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is Class II, and the recall involves a structural defect in a medical device (metal-on-metal articulation) which carries a risk of significant injury or adverse health consequences.

Plain-English summary

DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems. This notice applies to these specific stems when they were implanted with any metal-on-metal (MoM) articulation, including configurations with a cobalt-chromium (CoCr) head and an all-metal acetabular cup (monoblock or modular).

The LUSTER stems are forged CoCr polished cemented stems used as part of a total hip arthroplasty. They are indicated for use with all DePuy bearings and acetabular cups. The recall involves 85 LUSTER Cemented Polished Femoral Hip Stems across 69 lots. The product code is 152180001, and the affected lot numbers are A4TEH1000, A71EE1000, WF8A8101, X43FG1000, and Y82BD1000.

The products were distributed nationwide, including in California, Colorado, Iowa, North Carolina, Ohio, Texas, Washington, Wisconsin, and West Virginia. Patients who have had these specific hip stems implanted with metal-on-metal articulations should contact their healthcare provider to discuss the safety notice and potential next steps.

The recalled product

Product
LUSTER HIP SZ 1 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Orthopedic Implant
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Product code: 152180001 and Lot numbers: A4TEH1000
  • A71EE1000
  • WF8A81001
  • X43FG1000
  • and Y82BD1000.

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Part of a larger recall action

This product is one of 19 recalled by DePuy Orthopaedics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 19 products in this recall →

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