The reason for this revision surgery was reported as an infection and loosening.The previous surgery and the surgery detailed in this event occurred 1 year 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 devices were disposed of at hospital and not made available to djo surgical for examination.For item: 114904: the device history record was not found among djo and available zimmer biomet records for item: 540-00-000: a review of the device history record (dhr) show that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material report (ncmr) associated with the product that may have contributed to the reported event.The devices 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 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 infection and loosening.The findings did not lead to a firm conclusion since the needed records were not available at the time of this investigation.If more information is received later, the complaint will be updated.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 caused the loosening or contributed to the possible infection or inhibited the patient's immune system.There are multiple factors that may also contribute to an infection that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
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