SYNTHES GMBH ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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Catalog Number 04.168.485S |
Device Problems
Device Slipped (1584); Migration (4003)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Event Description
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Device report from synthes reports an event in japan as follows: it was reported that on september 11, 2023, the patient underwent an unknown surgery with fns implants for a femoral neck fracture.After the surgery, in (b)(6) 2024, the patient complained of pain.In addition, it was confirmed that only the anti-rotation screw was loose and protruded outward.No outward protrusion of the anti-rotation screw was observed in (b)(6) 2024.On (b)(6) 2024, all the fns implants were removed, and an artificial bone head replacement was done in the revision surgery.The revision surgery was completed successfully with no surgical delay.The cause of loosening of the anti-rotation screw is unknown.No further information is available.This report is for one antirotscr f/fem neck syst f/construct l this is report 1 of 1 for complaint (b)(4).
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Manufacturer Narrative
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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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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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Manufacturer Narrative
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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 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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Search Alerts/Recalls
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