It was reported that, after a left tka had been performed on (b)(6) 2022 with an unspecified system that contains an oxinium femoral component, the patient started experiencing significant swelling and fluid on the knee.The patient has gone to the hospital twice to have fluid drained from his knee.The patient is concerned about implant rejection.The patient also indicates that none of these issues happened with contralateral previous knee replacement that had been performed on 2019.Revision surgery has not been indicated yet; however, the patient is currently unable to walk, the swelling persists, and he continues experiencing pain.
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H3, h6: given the nature of the alleged incident, the device, could not be returned for evaluation.The clinical/medical investigation concluded that, per complaint details, the patient is experiencing persistent pain and significant swelling/fluid on the knee and is ¿unable to walk¿ approximately 9 months post tka with and unknown oxinium femoral component.Reportedly, the patient has gone to the hospital twice ¿to have fluid drained from his knee¿; however, a ¿revision (is) not indicated yet¿.Of note, the patient indicated ¿none of these issues¿ happened with contralateral tka in 2019.The requested medical documentation has not been received as of the date of this medical investigation.Correspondence reveals that medical records/operative notes are not available and the doctor/hospital ¿will not¿ accept patient calls or provide further information¿.The reported current health status ongoing symptoms/adverse event has not been resolved yet.Without the requested clinical documentation, possible contributing clinical factors could not be definitively concluded, and the source of the reported persistent pain with significant swelling/fluid on the knee and inability to walk cannot be determined.The patient impact beyond the reported symptoms and aspirations performed at the hospital cannot be determined; however ¿revision surgery has not been indicated yet¿.No further medical assessment could be rendered at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, post-operative healing issue, patient condition and/ or postoperative care.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 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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