Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent orif for femoral neck fracture with femoral neck system.On (b)(6), the agency received the call that the surgeon decided to remove the femoral neck system.On (b)(6), he commented that he used the femoral neck system even though the patient walks independently and has a strong retroversion.He expected bony fusion but decided to replace it with an artificial head since it was displaced to the point of near cutout.The replacement surgery is planned on (b)(6).No further information is available.This report is for one (1) lockscr ø5 self-tap l36 tan.This is report 2 of 4 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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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