The loosening reported was likely the result of either an insufficient bond between the implant and the bone, patient-related conditions related to medical history and/or previous operations on involved ankle, or a combination of the two.However, this cannot be confirmed as the patient has not yet been revised; therefore, the devices were not available for evaluation.Concomitant device(s): 350-22-62, tibial insert fb sz 2 rt 12mm, 350-02-01, talar implant sz 1 rt.
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As reported, the (b)(6) male patient presented with pain "like before my surgery" after beginning a walking program.Patient¿s bmi is (b)(6), weight is (b)(6).X-rays show cyst formation and early loosening in right ankle.The patient was instructed to reduce walking and return in 2 months.Patient has a history of post traumatic arthritis, hypertension, a-fib; pad; h/o pulmonary embolism & skin cancer.The case report form indicates this event is possibly related to devices or procedure.This event report was received through clinical data collection activities.
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