It was reported that, after tka surgery had been performed on (b)(6) 2014, the patient experienced instability on the implants.This adverse event was addressed by revision surgery on (b)(6) 2022 to explant the whole legion hk system.Current health status of patient is unknown.
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H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The device is covered in bone cement and connected to the corresponding device.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.The clinical/medical evaluation concluded that per complaint details, a hk tka revision was performed due to instability approximately 8 years post implantation.The requested clinical documentation has not been provided as of the date of this medical investigation.Per correspondence, ¿any other info was provided online, on the complaint¿.The patient¿s current health status is unknown, although it was reported that the revision was performed to ¿resolve the instability¿.The root cause of the reported event could not be further assessed.The patient impact beyond the reported laxity and subsequent revision could not be determined.No further medical assessment is warranted at this time.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.A review of the ifu for knee systems revealed in possible adverse effects that loosening, dislocation, subluxation, excessive rotation, flexion contracture, decreased range of motion, lengthening or shortening of the leg, looseness of components, unusual stress concentrations and extraneous bone can occur.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.The contribution of the device to the reported event could not be corroborated.Some potential probable causes for this event could include but not limited fit/sizing, alignment, surgical technique, joint laxity, traumatic injury and procedural/user error.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.
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