The reason for this revision surgery was reported as instability.The previous surgery and the surgery detailed in this event occurred 9 years and 9 months apart.Initial or prolonged hospitalization was required.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 hospital and not made available to djo surgical for examination.A review of the device history record (dhr) shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There was a nonconformance associated with the main part # 392-09-705, insert, 3d ex sz 5rt 9mm which documents that out of 17 parts lot, 2 parts were rejected and scrapped in which 1 part was rejected due to scratches in the area b and other part was rejected due to inclusion in the area c.All other items in the lot were met with the design, fit and function requirements.The device 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 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 instability.There were no findings during this evaluation that indicate the reported device was defective.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 also contribute to an event that are outside the control of djo surgical such as poor bone density, inadequate soft tissue support, patient activities or trauma.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.
|