Agency classClass IIOur severity:Severe FDA (Devices)·Z-1923-2012·Announced 2012-07-11

DePuy Recalls Luster Hip Stems Implanted with Metal-on-Metal Articulations

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

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device (metal-on-metal articulation) that poses a significant risk of injury.

Plain-English summary

DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for Luster Cemented Polished Femoral Hip Stems and 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 Cemented Polished Femoral Hip Stems are forged CoCr polished cemented stems used as part of a total hip arthroplasty. They were indicated for use with all DePuy bearings and acetabular cups. The recall involves 85 Luster Cemented Polished Femoral Hip Stems across 69 lots, with product code 152180009 and specific lot numbers including AE9GG1000, AH7DW1000, U5TA2C000, V1YEE1001, W1CBL1001, W5RF41001, W5RF41007, and Y84DW1000.

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 for guidance.

The recalled product

Product: LUSTER HIP SZ 9 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: metal-on-metal-wear
structural-defect

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 (8)

Product code:152180009 and Lot numbers: AE9GG1000
AH7DW1000
U5TA2C000
V1YEE1001
W1CBL1001
W5RF41001
W5RF41007
and Y84DW1000.

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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Same hazard · metal on metal wear