The reason for this revision surgery was due to distal humerus bone loss, proximal bone fracture.The previous surgery and the surgery detailed in this investigation occurred 2 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 a significant adverse event to the patient.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 implant device history records (dhr), shows that the reported component(s) used in the previous surgery, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the product(s) that may have contributed to the reported event.As of 24-sep-2018, the records needed, to verify an acceptable sterilization process, have not been forwarded by zimmer-biomet.Should zimmer-biomet provide the needed records at a later time, this investigation shall be updated.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 distal humerus bone loss, proximal bone fracture.There were no findings during this investigation that indicate that the reported device was defective.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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