Device report from synthes reports an event in australia as follows: it was reported that on (b)(6) 2022, the patient underwent femoral neck screw removal due to avascular necrosis.The fracture had healed.The fns was removed successfully, and a total hip replacement was implanted.This report involves one bolt for femoral neck system 95mm length-sterile.This is report 2 of 3 for (b)(4).
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.The initial reporter is a j&j employee.Part #: 04.168.295s.Lot #: l893800.The lot # l893800 does not exist.Dhr review cannot be completed.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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