Home arrow Biomet Hip Replacements
Biomet Hip Replacements

September 14, 2001-The FDA has announced the recall of hip implants that utilize the St. Gobain Desmarquest zirconia femoral heads, including ones used by Apex Surgical, LLC, Lakeville, Mass.; Biomet, Inc., Warsaw, Ind.; DePuy Orthopaedics, Inc., Warsaw, Ind.; Encore Orthopedics, Inc., Austin, Tex.; Osteoimplant Technology Inc. (OTI), Hunt Valley, Md.; Smith & Nephew, Inc., Memphis, Tenn.; Stryker Howmedica Osteonics, Allendale, N.J.; and Zimmer, Inc., Warsaw, Ind. The recall is due to a manufacturing defect. Patients with one of these hip implants should contact threir doctor.

 

HIP IMPLANTS BEING RECALLED; POTENTIAL FRACTURE PROBLEM


FDA today announced that eight U.S. firms that make hip implants are, or will be, voluntarily recalling certain of their hip implants due to a potential problem with a component.

The component, a zirconia ceramic femoral head, was recalled by its French manufacturer St. Gobain Desmarquest August 14 because it was fracturing at a higher rate than expected in some patients 13 to 27 months after being implanted. The component is the ball portion of the hip prosthesis that connects the femoral stem to the pelvis. St. Gobain Desmarquest distributes zirconia and alumina ceramic femoral heads worldwide to most of the orthopedic industry.

The French recall applies to nine batches of zirconia ceramic femoral heads manufactured since early 1998. The affected batches have the prefix "TH" before the batch number. All these potentially defective batches were manufactured after the beginning of 1998 when St. Gobain Desmarquest changed part of its manufacturing process. No metal or alumina femoral heads are involved in the recall.

U.S. companies estimate that hip implants with zirconia ceramic femoral heads are used in less than six percent of hip implant procedures in the United States. An estimated 150,000 to 200,0000 hip implants are performed annually in the United States.

Surgeons should not continue to implant artificial hips with zirconia ceramic femoral heads manufactured by St. Gobain Desmarquest since early 1998.

Patients who already have these hip implants should contact their surgeons with any questions or concerns. Not all zirconia ceramic femoral heads are expected to fail, and not all patients will experience a problem; therefore, FDA is not recommending surgery to replace hip implants that have not fractured or are not causing problems. Physicians will likely choose to monitor the performance of the implant more closely as a result of the potential problem.

Fracture of implants with this component is usually signaled by a sudden pain in the implanted hip joint, sometimes preceded by an audible "pop" from the hip just before the onset of pain. If a hip implant fractures, surgery to replace it will be necessary.

No tests exist that can predict which patients will experience failure of their hip implants because of defective zirconia ceramic femoral heads.

The U.S. companies that use the St. Gobain Desmarquest zirconia femoral heads are:

Apex Surgical, LLC, Lakeville, Mass.; Biomet, Inc., Warsaw, Ind.; DePuy Orthopaedics, Inc., Warsaw, Ind.; Encore Orthopedics, Inc., Austin, Tex.; Osteoimplant Technology Inc. (OTI), Hunt Valley, Md.; Smith & Nephew, Inc., Memphis, Tenn.; Stryker Howmedica Osteonics, Allendale, N.J.; and Zimmer, Inc., Warsaw, Ind.

Further details on the recall are available on FDA's web site at www.fda/gov/cdrh/recalls/zirconiahip.html. The current recall of hip implants is the second major hip implant recall in the past year. Sulzer Medica announced a voluntary recall of certain of its hip implants last December due to a lubricant residue on the implant that prevented it from bonding with the hipbone. Like Desmarquest, Sulzer's problem was traced to a change in a manufacturing process.



Biomet Hip Replacements FDA RECALL NOTICE

Medical Device Recalls
Recall of Zirconia Ceramic Femoral Heads for Hip Implants

he FDA is announcing a voluntary recall of the unimplanted inventory of nine batches of zirconia ceramic femoral heads manufactured by a French manufacturer, Saint Gobain Advanced Ceramics Desmarquest (St. Gobain Desmarquest), and by U.S. manufacturers that have included these components in their hip prostheses. The component is the "ball" portion of the hip prosthesis that connects the femoral stem to the pelvis.

On Tuesday, August 14, 2001, St. Gobain Desmarquest recalled nine specific production batches of its zirconia ceramic femoral heads, which include some lots sold in the United States. As a result, most orthopedic companies have either recalled or are in the process of recalling zirconia ceramic femoral heads manufactured by the French company. The zirconia ceramic components are distributed worldwide by more than 51 companies. U.S. companies estimate that zirconia ceramic femoral heads are used in less than 6% of hip implant procedures in the United States. About 150,000 to 200,000 hip prostheses are implanted into U.S. patients each year.

This recall follows recent action by the French Agency for the Medical Safety of Health Products (AFSSAPS) and the United Kingdom Medical Devices Agency suspending sales of all St. Gobain Desmarquest-manufactured zirconia ceramic heads made after a manufacturing process change in 1998. A letter published by AFSSAPS cited the higher than expected fracture rate in some of the product produced by St. Gobain Desmarquest, with several possible reasons for the increased number of fractures.
FDA is working with the U.S. industries, with Saint Gobain Desmarquest, and with the foreign regulatory agencies to help resolve this issue.

The orthopedic industry is working with various regulatory agencies around the world to determine whether and to what extent there are any performance issues with other production batches of zirconia heads manufactured by St. Gobain Desmarquest. The U.S. companies that are recalling the St. Gobain Desmarquest components are:

 

  • Apex Surgical, LLC (Lakeville, Mass.)
  • Biomet, Inc. (Warsaw, Ind.)
  • DePuy Orthopaedics, Inc. (Warsaw, Ind.)
  • Encore Orthopedics, Inc. (Austin, Tex.)
  • Osteoimplant Technology Inc. (OTI) (Hunt Valley, Md.)
  • Smith & Nephew, Inc. (Memphis, Tenn.)
  • Stryker Howmedica Osteonics (Allendale, NJ)
  • Zimmer, Inc. (Warsaw, Ind.)

Meanwhile, surgeons should not implant artificial hips with the St. Gobain Desmarquest zirconia ceramic heads manufactured since the process change in 1998.

Important points to consider:

  • The recall applies only to unimplanted zirconia ceramic femoral heads.
  • No metal or alumina femoral heads are involved in the recall. There is no known concern for any metal or alumina femoral heads.
  • Zirconia ceramic femoral heads manufactured before 1998 are not being recalled.
  • Although the failure rate is higher than expected, not all zirconia ceramic femoral heads made by St. Gobain Desmarquest after 1998 will fail. It is important to note, therefore, that there are patients who have these zirconia ceramic femoral heads made after 1998 who will not experience failure of their implants.

For patients who already have this implant:

  • FDA is not recommending surgery to replace any hip implants that have not fractured or are not causing problems.
  • There are no tests that can predict which patients will experience failure of their hip implants because of defective zirconia ceramic femoral heads.
  • Physicians will likely choose to monitor the performance of the implant more closely as a result of the ongoing issue. Physicians should watch for patients complaining of the sudden onset of pain in the implanted hip joint. Patients may report that they heard a 'pop' from their hip just before the onset of pain
  • Patients should contact their surgeons with any questions or concerns.

FDA Contact: Consumer Relations Staff, CDRH, at 888-Info FDA or 888-453-6332.

 

Updated September 13, 2001
 
Complete this form for a free claim evaluation