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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Necrosis (1971); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown nail head elements: fns antirotation/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.(b)(4).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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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date, the patient underwent surgery for femoral neck fracture with the fns.In (b)(6) 2020, the surgeon confirmed that bone head necrosis occurred.On (b)(6), the patient underwent revision surgery to remove the fns and perform bha surgery.The surgery was successfully completed.No further information is available.This report is for one (1) unk - nail head elements: fns antirotation.This is report 2 of 4 for (b)(4).
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Search Alerts/Recalls
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