ARTHREX, INC. UKA TIBIAL BEARING, SIZE 3, 11MM, VIT-E; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number UKA TIBIAL BEARING, SIZE 3, 11MM, VIT-E |
Device Problems
Difficult to Insert (1316); Material Deformation (2976); Physical Resistance/Sticking (4012)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
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Event Description
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It was reported that during a right uka procedure, the surgeon had reached the implant insertion step of the technique.He attempted to insert a size 3, 11mm vitamin e tibial poly bearing, ar-521-tbc1; however was meeting resistance during insertion.After pulling the poly bearing out of the joint, the poly was noticed to be deformed.A second size 3, 11mm vitamin e tibial poly bearing, ar-521-tbc1, was opened and the surgeon met the same issue when trying to insert the poly bearing.Again, the poly bearing was found to be deformed.The surgeon took bone away and tried to expose the joint as much as possible with no luck in getting the poly bearing to seat.A third poly bearing was opened and this time, the surgeon tried a size 3, 11mm tibial poly bearing, ar-501-tbc1.As he was attempting to insert this poly bearing, the same issue was present, the poly could not be seated and was found to be deformed after being removed.After a 15 minute delay in case, the surgeon was finally able to implant and seat a fourth size 3, 11mm tibial poly bearing, ar-501-tbc1, with no adverse effect to the patient.
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