The reason for this reported incident was due to left side - left knee instability.This event did not involve the devices being removed.This analysis is limited in scope as the devices associated with this event remain in the patient, therefore will not be returned to djo surgical - austin for examination.If additional information regarding the event is submitted at a future date, this analysis will be re-evaluated.A review of the device history records (dhr) shows that the reported devices used in the primary surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the devices that may have contributed to the reported event.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of use during the primary surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are in need of review.The root cause of this event is due to left side - left knee instability.There were no findings during this analysis that indicate that the reported devices were defective.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
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