It was reported that a (b)(6) year-old female had the primary hip replacement (spectron/ r3) (b)(6) 2017.Patient complained of ongoing gluteal pain.Ct review in 2019 shows acetabular screw protruding posteriorly.The patient referred to a sports doctor who advised cortisone injection around this screw which temporarily relieved pain.The surgeon recommended revision surgery to remove screw.During surgery, liner, femoral head and acetabular screw were removed following recommended surgical technique with nil issues, new liner and femoral head implanted.
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It was reported that a revision surgery was performed approximately 2.5 years post-implantation.Ct review shows acetabular screw protruding posteriorly.The patient reportedly underwent a revision which included explantation of the screw, along with the head and liner.The affected complaint devices, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.Review of the ifu and risk management files identified the reported failure as potential adverse events.A medical analysis noted that the provided photos of ct imaging confirm a posterior protrusion of a screw through the pelvis.Comparison images were not available for inclusion in the medical investigation; therefore, screw migration could not be confirmed.The screw protruding into the soft tissues, however, was most likely the contributing factor to the ¿ongoing gluteal pain¿.Based on this investigation, the need for corrective action is not indicated.Some potential causes could include but are not limited to alignment, patient anatomy or abnormal loading of limb.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, this complaint will be reopened and reevaluated.
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