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For orthopedic doctors, it has been called their “worst nightmare come true” and described as the “Firestone version of medical
hell.”
One hip implant recipient has stated, “I’d like to walk down the street holding my husband’s hand instead of a crutch or a walker. I just want my life back.” Another patient sadly commented that she has been in “excruciating pain” for almost a year.
This has been the reaction to the recall announced on December 8, 2000, by Sulzer Orthopedics of its Inter-OpTM acetabular shell for hip implants. These implants were sold primarily after October, 1999, with a small number of lots sold after July, 1997. Approximately 17,500 patients are affected by the recall.
Sulzer has stated that after introduction of the product in the U.S., it began receiving reports of post-operative loosening of a number of
the shells. Testing of the shells reportedly revealed a lubricant residue that was used in the manufacturing process.
This residue may cause a reaction in your body that prevents your bone from bonding with the hip implant. Loosening of the shell may occur because of this reaction.
According to Sulzer, there are specific hip symptoms associated with this problem.
If you have pain in your inner thigh or groin, pain when arising from a seated position or pain with standing and weight bearing, you may want to consult with your doctor. Your surgeon can retrieve the specific lot number used in your hip replacement surgery from your medical records, in order to determine if the hip shell you received is covered by the recall.
A Sulzer spokesman has admitted the problem “was ultimately a fault of one of our products.”
Sulzer has agreed to reimburse patients solely for medical expenses related to replacing a recalled hip implant, but only in the limited circumstances in which the patients shows that these medical expenses are not covered by the patient’s private medical insurance or government Medicare.
Sulzer has not publicly offered to compensate patients for any of their pain and suffering, future medical care and physical therapy, lost
wages and earnings, or non-medical expenses incurred as a result of receiving the recalled hip implant.
People who received the Sulzer devices are in most states entitled to recover for these losses if actually incurred.
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