The Recall Desk
HighFDA (Devices)·Z-1921-2012·Announced 2012-07-11

DePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Concerns

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

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a Class II medical device with a risk of harm associated with metal-on-metal articulations, but the source text does not report specific injuries or illnesses, fitting the High severity criteria for risk-of-harm products without reported injury.

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. This includes configurations where the femoral head is made of Cobalt-Chromium (CoCr) and the acetabular cup is of an all-metal construction, whether 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 are indicated for use with all DePuy bearings and acetabular cups. The recall involves 85 LUSTER Cemented Polished Femoral Hip Stems in 69 lots, with product code 152180007. The affected lots include A1XEF1000, A21BV1000, A4NBV1000, A6BB31000, AB1H31000, AV1A71000, AV7FL1000, BB8E21000, BV8FT1000, VG3BSB000, X5XD21000, Y64ET1000, Z12DG1000, and Z1PJE1000.

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 Field Safety Notice and determine if any further action is necessary.

The recalled product

Product
LUSTER HIP SZ 7 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 Implants
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 (14)

  • Product code:152180007 and Lot numbers: A1XEF1000
  • A21BV1000
  • A4NBV1000
  • A6BB31000
  • AB1H31000
  • AV1A71000
  • AV7FL1000
  • BB8E21000
  • BV8FT1000
  • VG3BSB000
  • X5XD21000
  • Y64ET1000
  • Z12DG1000
  • and Z1PJE1000.

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 →

Related recalls

Same manufacturer · DePuy Orthopaedics, Inc.

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Same hazard · metal on metal articulation

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