The reason for this revision surgery was reported as an infection.The previous surgery and the revision detailed in this investigation occurred 7.8 months 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.Initial or prolonged hospitalization was required.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 implant device history records (dhr), shows that the reported components used in the previous surgery met design and manufacturing requirements.There was one (1) non-conforming material report (ncmr) associated with the part 530-12-108 (lot-412t1116) listed in the complaint.Non-conforming material report-(b)(4) documents 15 parts for v14 - other visual (suture holes drilled into porous caoting) disposition-uai (use as is), justification (this will not affect the fit or function of this part.This is a visual non-conformance only).Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The device was verified to have gone through an acceptable sterilization process and was within it's expiration date at the time of use during the previous surgery.There were no findings during this investigation that indicate that the reported device was the root cause or had a direct connection with the patient's infection.There are multiple factors that may contribute to an infection that are outside of the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.
|