The reason for this revision surgery was due to a fracture.The previous surgery and the revision detailed in this investigation occurred over 2 years and 1 month 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 the implant device history records (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements.There was a non-conformance associated with the part 530-12-108, encore reverse shoulder humeral stem, standard, size 12x108 millimeter that out of 15 quantity lot, 1 item was rejected and scrapped due to ml02 (material defect) part was bent.All other 14 items were accepted.All other items in the lot met the design, fit and function requirements.The device and its applicable concomitant devices were within their respective expiration dates at the time of use during the previous surgery.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 a fracture.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's event.There are multiple factors that may contribute to fracture that are outside the control of djo surgical such as: poor bone density, patient noncompliance with medical instruction, patient activities or trauma.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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