Alere San Diego, Inc., FCA-001-22; MDSS ref.: IVD22.018, Cholestech LDX Test Cassettes

During a recent review of its knee implant manufacturing process, Exactech learned that one of the packaging layers for the plastic insert has been out-of-specification and may allow oxygen from the air to diffuse into the plastic insert prior to it being implanted in your knee. If a large amount of oxygen diffuses into the plastic insert while it's being stored and before it is implanted, this can lead to a process called oxidation, which can cause the plastic to wear out earlier than expected or to become damaged after it is implanted into the patient's body. Oxidation increases during the shelf life of the product and therefore the risk of revision for polyethylene wear is greatest for patients who have polyethylene inserts that were on the shelf for greater than five years.
Exactech has found that the tibial plastic insert in the out-of-specification bag can wear out earlier than expected in some patients. Premature wear of the plastic insert of your knee replacement can lead to the need for additional surgery (also known as revision surgery). In those cases where the plastic has worn out earlier than expected or has been damaged, we will evaluate your knee replacement and decide whether additional treatment is needed. Determination of whether the plastic is worn is accomplished by examining your knee in the office and obtaining x-rays. After this evaluation is complete, we will decide if additional treatment, including revision surgery, is necessary.