The reason for this revision surgery was reported as instability.The previous surgery and the surgery detailed in this event occurred 25 days 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 the hospital and not made available to djo surgical for examination.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the products 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 the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to instability.There were no findings during this evaluation that indicate that the reported devices were defective.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 of the control of djo surgical such as poor bone density, patient bone deterioration, inadequate soft tissue support, excessive range of motion, patient activities or trauma.Due to the short time between previous and revision surgery, it is also possible that the event may have been occurred due to lack of post-operative care, patient non-compliance with medical instructions, improper surgical technique or incorrect implant selection.There are no indications of a product or process issue affecting implant safety or effectiveness.
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