It was reported that, after a tka surgery had been performed on (b)(6) 2016 with a legion porous system, patient felt right knee hematogenous infection.A right knee incision and drainage with revision of articular surfaces treatment was performed to resolve the reported event.
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H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a bilateral articular insert revision with incision and drainage was performed approximately 5.5 years post implantation due to ¿patient felt right knee hematogenous infection¿.The requested clinical documentation has not been provided as of the date of this medical investigation; however, it was reported that the aemb cannot exclude the contribution of the device to the infection.The event occurrence date was reportedly 10-dec.2021 with a status of ¿resolved¿.Without the requested clinical documentation, the root cause of the reported event could not be further assessed.The patient impact beyond the reported infection.I&d and articular insert revision could not be determined.No further medical assessment could be rendered at this time.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed that acute post-surgical wound infection have been identified as a possible adverse effect.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 product specifications at the time of manufacture.Possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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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