(b)(4).Manufacturer narrative: the reason for this revision surgery was due to loosening.The previous surgery and the surgery detailed in this investigation occurred 1.1 years apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.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 item: 114906 device history record (dhr) was not conducted since as of (b)(6)2019, no records have been made available.Should the records needed for review become available, the complaint will be re-opened and a review will be conducted.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to loosening.The surgeon performed this procedure to remedy the patient's condition.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
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