It was reported that, after a tka, a revision of the polymer insert had to be performed on (b)(6) 2023 because the patient felt discomfort.There were no other complications reported, 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 the supporting clinical documentation has not been provided; therefore, a definitive clinical root cause of the reported event cannot be confirmed nor concluded.The patient impact beyond the reported insert revision due to discomfort cannot be determined.No further medical assessment could be rendered at this time.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management file and prior actions review could not be performed.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 size selected, joint laxity, patient condition or postoperative care.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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