The reason for this revision surgery was due to instability.The previous surgery and the revision detailed in this investigation occurred 42 days 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-conforming material report (ncmr) # 41786 associated with the part # 508-36-101, glenoid, head with retaining screw, reverse shoulder prosthesis (rsp), 36 millimeter / neutral which documents a nonconformance that out of 15 quantity lot 1 item was rejected due to handling induced scratches on articulating area of the head.It was reworked with suitable operations and accepted.All other items in the lot met design, fit and function requirements and were accepted.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 instability.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the event.There are multiple factors that may contribute to the event that are outside the control of djo surgical such as: poor bone density, inadequate soft tissue support, excessive range of motion, patient activities or trauma.Due to the short time between the previous and revision surgery, it is also possible that the event may have occurred due to improper surgical procedure, improper implant selection or patient non-compliance with medical instructions.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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