The reason for this revision surgery was the wrong size ulna implant was cemented into the patient; remedial action was required.The length of in-vivo service of the implant is unknown since an original surgery date could not be established.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.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 left in the patient and not made available to (b)(4) for examination.A review of the device history record and investigation history was not conducted since a lot number was not provided or could be established for the original explanted part.A search the (b)(4) patient database was not conducted since biomet products and surgeries are not included at this time in the historical records.This event is deemed to be non-product related.The complaint report states the wrong size ulna implant was cemented into the patient.No other conditions relating to this event could be determined with confidence.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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