It was reported that, after a right high flex unicondylar knee replacement had been performed on (b)(6) 2020, the patient experienced pain, swelling, and stiffness immediately post-op.There has not been any improvement in pre-op symptoms with progression over time.Patient has been treated with systemic nsaids, systemic glucocorticoids, leflunomide, and adalimumab.The event is ongoing.
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Section 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, immediately post-op right hf uni-knee replacement performed on 03-nov-2020, the patient ¿with no comorbidities¿ experienced ¿no improvement in pre-op symptoms with progression over time, pain, swelling and stiffness¿.Reportedly, the patient has been treated with systemic nsaids, systemic glucocorticoids, leflunomide, and adalimumab without resolution.It is unknown if the patient has a pre-existing and/or undiagnosed allergy to one or more of the implanted biomaterials.Of note, the patient reportedly had the contralateral knee replaced approximately 2 months prior and has the same reported symptoms.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, no clinical factors could be confirmed to have contributed to the reported event.The patient impact beyond that which was reported could not be determined.No further medical assessment is warranted 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.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction, alignment, fit/size of device used, wear or loss of sterility.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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