Consumer Alert: St. Gobain Prozyr® Zirconia Ceramic Coated Femoral Head Hip Implant Components
February 2002
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Following earlier recalls in Britain and France, the United States Food and Drug Administration announced on September 14, 2001 a voluntary recall of hip implants that incorporated a ceramic femoral head component manufactured by St. Gobain Desmarquest, also known as Saint Gobain Advanced Ceramics Desmarquest. The affected products are also described as Prozyr® Zirconia Heads. The femoral head is part of the hip implant system that is inserted into the femur, the large bone in the top half of the leg. The femoral head is the ball component of the artificial hip "ball and socket" joint.
A change in the manufacturing process that negatively affected the production of the femoral head implant components from January 1998 to September 1999 is believed to have led to the recall. The recall extends to the non-implanted inventory of nine lots of femoral head hip implant components manufactured by St. Gobain during this timeframe. No implants manufactured before 1998 are involved.
According to documents produced by St. Gobain, there are approximately 9,051 femoral head components in the affected lots. The exact number of these 9,051 femoral heads that had already been surgically implanted into patients prior to the recall is presently unknown. As of February 4, 2002, St. Gobain admitted being aware of 162 breakages of the ceramic heads, each of which then required extensive revision surgery to remove and replace.
More than 50 orthopedic implant device companies utilize ceramic components manufactured by St. Gobain. U.S. companies using these ceramic components include:
- Apex Surgical LLC
- Biomet, Inc.
- DePuy Orthopedics, Inc.
- Encore Orthopedics, Inc.
- Osteoimplant Technology, Inc.
- Smith & Nephew, Inc.
- Stryker Howmedica Osteonics
- Zimmer, Inc.
Unfortunately for those patients with ceramic femoral head hip implants already in place, according to Zimmer, Inc., "[t]here are no tests that can predict which patients will experience failure of the defective zirconia ceramic femoral heads." Signs of failure and/or fracture of these ceramic femoral head implants include hip joint pain, leg pain, inability to bear weight on the leg and "start up" pain (experienced when attempting to stand or rise from a seated position).
Batch Numbers of the Prozyr® Zirconia Head implants involved in the recall are:
Batch Numbers | Diameter | Design |
TH/ 93038 | 28 | 109355/D
190364/B
190572/A
190215/B |
TH/ 2957 | 28 | 190514
190515
190576/A
190532/A
ou
190533/A
190332/D
190162/F |
TH/ 94877 | 28 | 195027/A |
TH/94878 | 28 | 190235/B |
TH/ 94879 | 28 | 190333/B |
TH/ 98260 | 28 | 190590&A |
TH/ 98282 | 22 | 190636 |
TH/ 3736 | 28 | 190515 |
TH/ 4515 | 28 | 190590/A |
TH/ 4650 | 28 | 190590/A |
TH/ 4652 | 28 | 190590/A |
TH/ 9382 | 28 | 190589 |
Anyone who believes they may have received one of these recalled femoral head implants should contact their doctor.
As with the Sulzer Orthopedics Inter-Op Hip™ and Natural Knee™ II implants (each of which has been previously recalled due to contamination by unacceptable levels of machine oil residue), there are a great many lawsuits already filed in both state and federal courts involving the Prozyr® Zirconia Head implants. Our offices have been and continue to be involved in and committed to the prosecution of these actions on behalf of the victims of these defectively manufactured products. Please feel free to contact our offices for further information concerning the recall of these Prozyr® Zirconia Head implants.
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