The reason for this revision surgery was due to metallosis.The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could 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.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 device history records (dhr) was not conducted since the item and or lot number was not provided or determined during the complaint evaluation.As of 22-may-2018, the records needed have not been forwarded by zimmer-biomet.Should zimmer-biomet provide the needed records at a later time, this investigation shall be updated.The root cause of this complaint was a revision surgery due to metallosis.The surgeon performed this procedure to remedy the patient's condition.This complaint will be closed with the item and or lot number(s) unknown pending receipt of additional information.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.
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