(b)(4).This report is number 3 of 4 mdrs filed for the same patient (reference 0001822565-2017-04518 / 0001822565-2017-04519 / 0001822565-2017-04521).Concomitant devices ¿ zimmer talar component orange size 4 right catalog # 00450002400, lot # 77003947; zimmer prolong tibial insert sz 4 +0 catalog # 00450005400, lot # 62579583; zimmer distal lateral fibular plate right 6 holes 106 mm length catalog # 00235701706, lot number #unknown; zimmer palacos cement catalog #: ni, lot #: ni.The complaint device is not expected for return currently, as it remains implanted, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.The investigation is in process.
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It was reported that patient underwent a right ankle procedure.Subsequently, the patient experienced mild swelling, mild stiffness, mild tenderness, mild weakness, mobility issues, some issues with performing usual daily activities, and moderate pain or discomfort noted at six (6) week post-operative follow-up.At the six (6) month post-operative follow-up, mild swelling, mild stiffness, mild to moderate pain or discomfort, and some range of motion restrictions were noted, however it also noted the ankle was better and the patient was satisfied.At the one (1) year post-operative follow-up, mild swelling, mild stiffness, and some problems with performing usual daily activities, moderate pain or discomfort, and some range of motion restrictions.At the two (2) year post-operative follow-up, mild swelling, mild stiffness, some problems with walking, moderate pain or discomfort, and some range of motion restrictions were noted.Additionally, osteolysis was noted on radiograph findings.The patient continues to report that they are satisfied and that the ankle is improving.No further treatment has been indicated at this time.
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