As reported by the exactech cc clinical study, approximately three months post tka, the patient went to er because concerned about persistent pain radiating down lateral side of right leg all the way to foot.The event is possible related to the device and the procedure.
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After further review of additional information received.(h3) as reported by the exactech cc clinical study, approximately three months post tka, the 50 y/o patient went to er because concerned about persistent pain radiating down lateral side of right leg all the way to foot.The patient complained of instability, pain and stiffness.The patient has a history of heart disease, diabetes, and has smoked for 38 years.The patient also has a history of hx breast cancer, copd, asthma, osa, depression.The event is possible related to the device and the procedure.Per ifu#: 700-096-004: postoperative counseling and care is important.It is recommended that regular, long-term postoperative follow-up be undertaken to detect early signs of component wear and loosening, and to consider the course of action to be taken if such events occur.A suitable rehabilitation program should be designed and implemented.A continuing periodic follow-up is recommended.Periodic x-rays should be taken to detect evidence of positional changes, loosening, bone loss, and/or device fracture.In such cases, patients should be monitored, and the benefits of revision surgery should be considered to avoid further deterioration.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the pain and subsequent revision cannot be conclusively determined; however, it is most likely is related to the patient¿s underlying condition.
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