The reason for this revision surgery was due to dislocation.The in-vivo length of patient service for the implant was 4 months.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 the implant device history records (dhr) shows that the reported components used in the previous surgery met design and manufacturing requirements.There was a ncmr# (b)(4) associated with the part 530-08-108, altivate reverse humeral stem, size 8mm standard which documents a nonconformance that out of 15 quantity lot 1 item was scrapped due to damaged porous coating.All other items in the lot were met the fit, design and functional requirements.The device and its applicable concomitant device were within their respective expiration dates at the time of use during the previous surgery.Customer complaint history of the reported device (s) showed no present trends or on-going issues that are in need of review.This event is deemed to be non-product related.The root cause of this complaint was a revision surgery due to the dislocation.There are multiple factors that may contribute to the event that are outside the control of djo surgical are patient activities, inadequate soft tissue support, excessive range of motion, patient bone deterioration, degenerative tissue or trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities that may have contributed to the event and hence a definitive root cause cannot be determined.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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