The reason for this revision surgery was due to aseptic loosening of the humeral stem.The previous surgery and the revision detailed in this investigation occurred 1.1 years 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 a significant adverse event to the patient.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 item: 114914 device history records (dhr), shows that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the reported event.As of 6-apr-2018, the needed records and the records needed to verify an acceptable sterilization process 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 aseptic loosening of the humeral stem.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.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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