The reason for this revision surgery was reported as loosening.The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could be established.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.Because of the acquisition by djo surgical, an extended search of zimmer biomet records cannot be conducted.Any records before the acquisition date, that have not been forwarded, will not be made available.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 a revision surgery due to loosening.The findings did not lead to a firm conclusion since the needed records were not made available at the time of this investigation.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.
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