(b)(4) combined report.It was reported that the patient fell post-op, thus resulting in a periprosthetic fracture and the subsequent revision.Operative notes, x-rays, patient medical history and the explants could not be provided.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.As this event was the result of the patient experiencing a periprosthetic fracture following a fall, and not due to the design or performance of the corin devices, no further investigation is required and thus this case is now considered closed.Please note: this report is filed with the fda due to an event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.
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