It was reported that, after a thr surgery was performed on (b)(6) 2001, the patient experienced pain and migration of the implant.This adverse event was treated by a revision surgery on (b)(6) 2022, in which an integral bipolar cup set 44mm was explanted.Patient's current health status is unknown.
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The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.Procedure was completed with a back-up device.No injury to the patient was reported.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed that implant migration or subsidence that has resulted in revision surgery and has occurred in conjunction with compaction grafting procedures can occur usually as a result of insufficient graft material, improper cement techniques, and/or varus stem alignment has been identified as an adverse events in primary and revision surgery.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include patient anatomy and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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