It was reported that, after a thr surgery was performed on an undisclosed date, the patient experienced left hip dislocation.This adverse event was treated with medication and surgery, however the patient remains recovering.Patient's current health status is unknown.
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H3, h6.The devices were 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 dislocation.It is noted the event was addressed with medication and surgery.It's noted the patient was recovering.The patient impact beyond the reported events cannot be determined with the information provided.No further clinical assessment is warranted at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the shell and the liner, a review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.For the insert and the head, a review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total hip systems revealed that dislocation has been identified in warnings and precautions section as a result of improper neck selection, positioning, looseness of acetabular or femoral components, extraneous bone, penetration of the femoral prosthesis through the shat of the femur, fracture of the acetabulum, intrapelvic protrusion of acetabular component, femoral impingement, periarticular calcification, and/or excessive reaming.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.For the shell, the insert and the head, a historical review concluded that there are no prior actions related to these products and event.For the liner, a historical review concluded that a similar event was previously identified.The listed batch was not part of the impacted product.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, patient anatomy, postoperative care or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should the devices 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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