It was reported that, after a tka surgery was performed on an unspecified date, the patient experienced an unspecified adverse event.This event was treated with a revision surgery on (b)(6) 2022, in which an incision and drainage (i&d) was conducted and a jrny ii isrt xlpe dd rt sz 3-4 11mm was exchanged.Patient's current health status is unknown.
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Section h3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The photograph was reviewed, and revealed signs of use.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.A single undated, unlabeled photo of an insert was provided; however, the photo does not aid in determining the clinical root cause of the reported adverse event.The impact to the patient beyond the reported revision, the incision and drainage procedure and the jrny ii isrt xlpe dd rt sz 3-4 11mm exchange could not be confirmed nor concluded.Since the patient's current health status is unknown, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.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.With the results of this investigation the root cause of this event could not be determined.No details of the alleged fault, malfunction or injury were provided, therefore no factors that can contribute can be delineated.Based on this investigation, the need for corrective action is not indicated.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.B5: describe event or problem.
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It was reported that, after a tka surgery was performed on an unspecified date, the patient experienced an unspecified adverse event.This event was treated with a revision surgery on (b)(6) 2022, in which an i&d procedure was conducted and a jrny ii isrt xlpe dd rt sz 3-4 11mm was exchanged.Patient's current health status is unknown.
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