Letter To Patient

December 19, 2000

Dear Patient,

Sulzer Orthopedics is the manufacturer of a hip implant that you received during hip replacement surgery. We sincerely regret to inform you that we have recently learned that a small number of the many implant parts that we manufactured may have a trace of lubricant residue on the surface that was not completely removed during the manufacturing process.

We recently discovered this residue and immediately recalled the affected products. We have teams of experts, including independent scientists, investigating this issue. Based on current information very small amounts of residual lubricants are broken down and eliminated by the body. At the moment, the only known problem is not enabling the bone to bond with the affected hip implant. This information is currently being confirmed with independent scientists. Your surgeon will be advised of the results of this investigation.

The hip implant part is the acetabular "shell" which was implanted into the upper part of your hip called the acetabulum. Normally, the bone would form an integrated bond with the shell; however, it appears that bone does not always bond with shells when the lubricant residue is present. Reported symptoms include severe groin pain and inability to bear weight on your leg. These symptoms are caused by the shell being loose from the bone. Only a small number of patients who received the shell during their total hip replacement have experienced loosening of the shell. If you are experiencing these symptoms, please contact your physician.

Please note that our surgeon advisors do not recommend that patients undergo removal of the part unless they exhibit symptoms of loosening.

We at Sulzer Orthopedics apologize for any effect that this voluntary recall may have on you. We will do our very best to address your individual needs and concerns that are a result of this recall. We know that one of your concerns will be the additional costs that you may incur because of further medical attention. Please rest assured that Sulzer Orthopedics will reimburse you for your related out-of-pocket expenses not reimbursed by insurance or Medicare. Sulzer Orthopedics is dedicated to resolving any healthcare problems associated with this implant recall and will cover any costs involved.

To assist you, and to answer some of the questions you may have, we have set up a toll free telephone number for you to call. The number is XXX-XXX-XXXX ext. XXX.

Sulzer Orthopedics is committed to improving the quality of life by advancing orthopedic medicine. We are committed to working with your surgeon to provide information needed to assure proper diagnosis and treatment is available for each individual patient.

Sincerely,

Gary Sabins

President, JC/FC