The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the provided x-rays were reviewed but do not aid in determining a clinical root cause of the reported infection, as the infection cannot be viewed on the images.However, the one of the undated x-ray images does appear to show a void in the femoral cortex around the stem which could indicate fracture or a remaining void from a previous procedure (such as cerclage cable or cortical screw).The reported infection is highly likely of an exogenous nature, and it cannot be concluded the reported infection was associated with the implant.The patient impact is the reported infection and subsequent incision and drainage and revision.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.A review of the risk management files 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 products and event.A review of the instructions for use documents for total hip systems revealed infection, both early, post-operative superficial and early, post-operative deep wound infection and late periprosthetic infection has been identified in potential complications associated with total hip arthroplasty surgery, primary or revision section.A review of the sterilization records revealed the batches were sterilized within normal parameters.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include loss of sterility during procedure, post-operative healing issue, injury, patient condition and/or medical history.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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It was reported that, after a primary thr performed on (b)(6) 2023, a revision had to be carried out on (b)(6) 2023 due to infection of the hip replacement.The infection included the deep tissues and debridement and washout of all layers was performed.The primary femoral head and taper sleeve were explanted.Further debridement of tissue within the hip joint and around the femoral stem was also undertaken.Patient's current health status is unknown.
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