The reason for this revision surgery was due to a possible infection, awaiting cultures.The previous surgery and the revision detailed in this investigation occurred over 11.6 years apart.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the infection or inhibited the patient's immune system.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 not made available to djo surgical for examination.A review of the implant device history records (dhr) and verification of an acceptable sterilization process could not be conducted.The records needed for review were not made available at the time of this investigation.As of 1-mar-2018, no records have been forwarded by zimmer-biomet concerning this event.Should zimmer-biomet provide additional information at a later time, this investigation shall be re-evaluated.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 possible infection, awaiting cultures.There are multiple factors that may contribute to an infection that are outside of the control of djo surgical.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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