The reason for this complaint was reported as product being switched after the sterilization process.The healthcare professional indicated this event occurred during surgery, away from the patient and there was a significant adverse event to the patient.There was a four to five minutes delay in surgery but the surgery was completed as intended.The agent was present during surgery and had another suitable device available.The device was returned to manufacturer and evaluated by registered medical assistant (rma) djo surgical.A review of the device history records (dhr) indicate twenty (20) pieces of 942-01-40h, acetabular liner, lot 629z1085, were processed on work order (b)(4).These parts went through the sterilizer run (b)(4).Twenty (20) pieces of 341-14-709, knee insert, lot 132t1085, were processed on work order (b)(4).These parts went through the sterilizer on run (b)(4).Both work orders were processed by the same operator.The label on the bottom tray matches the work order and packaged part; however, the label on the front of the tray and outer packaging were swapped.Complaint database indicates one other instance occurring for the same product and lot numbers.The surgery took place on the same day.No prior complaints report past instances of these instruments being affected by this failure.The root cause of this complaint is likely due to the product being switched after the sterilization process.(b)(4) was opened to capture the containment process for this issue.Rma examination: the reported devices were returned to djo surgical for evaluation.It is confirmed that the packaging for the empowr 3d knee insert contained an acetabular liner.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
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