Manufacturer data: the reason for this revision surgery was reported due to dislocation.The previous surgery and the surgery detailed in this event occurred 2 days 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.A review of the device history records show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There was a ncmr# (b)(4) associated with the main part #508-32-101, glenoid, head w/retaining screw, rsp, 32mm/neutral, which documents that out of (b)(4) parts lot, 1 part was rejected due to a ding on the outer rim and scratches on the polish surface.Later the rejected part was reworked and accepted after proper justification via spar (standard pre approved rework).All other items in the lot were met with the design, fit and function requirements.The devices were 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 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 dislocation.There were no findings during this evaluation that indicate the reported devices were 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 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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