It was reported the patient was implanted with a competitor's femoral plate and allograft strut for a vancouver c fracture and required a revision due to non-union.The plate was reported to have been removed for the non-union with no issues and the plate was reported to be intact.The patient was revised to a synthes variable angle condylar plate, cables, allograft strut.The surgeon implanted a long plate which overlapped the stem and used screws aimed anterior to the stem and cables.An allograft strut was placed on the anterior aspect of the femur and cable.It was reported through x-ray that the synthes plate broke at the same location of the non-union site after the patient was instructed to apply weight as tolerated.The patient was reported to have heard a crack on (b)(6) 2014 which could have been when the plate breakage occurred.It was further reported the patient is quite small and light weighted leading the surgeon to expect the plate to support her partial weight bearing.The revision surgery was delayed as the patient was reported to be febrile.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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