Corrected data: manufacturer narrative: the reason for this revision surgery was reported as an loosened implants.The previous surgery and the surgery detailed in this event occurred 2.7 years 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.Item: 114905.The device history record was not found among djo and available zimmer biomet records.Item: 114700.A review of the implant device history records (dhr) shows that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There was no non-conforming material reports (ncmr) associated with the product that may have contributed to the reported event.The device 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 loosened implants.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.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.If more information is received later, the complaint will be updated.The surgeon performed this procedure to remedy the patient's condition.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
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