The reason for this revision surgery was reported as a worn tibial insert.The previous surgery and the surgery detailed in this event occurred 7 months apart.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at hospital and not made available to djo surgical for examination.A review of the device history record (dhr) shows that the tibial insert used in the previous surgery met design and manufacturing requirements when released for use.There were no non-conforming material reports (ncmr) associated with the implant that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are needing a review.The root cause of this complaint was revision surgery due to a worn tibial insert is third body wear.There were no findings during this evaluation that indicate the reported device was defective.Possible sources of third body wear are cement or bone debris.The pitting and wear on the implant's articulating surface were likely caused by debris from the surgery.This caused some resistance in the movement between the implanted parts, which may explain the patient's pain, and swelling.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.
|