SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Joint Dislocation (2374)
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Event Type
Injury
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Event Description
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Device report from synthes (b)(6) reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent a surgery with the femoral neck system (fns) plate for the fracture of the femoral neck approximately three years earlier.The patient complained of pain, and it was confirmed that the varus dislocation of the femoral bone head with pseudarthrosis occurred in (b)(6) 2022.Therefore, the surgeon removed the plate and perform the bipolar hip arthroplasty on (b)(6) 2022.This report is for an unknown fns antirotation nail head element.This is report 2 of 4 for (b)(4).
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Manufacturer Narrative
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Exact date of event is unknown; event occurred sometime between implant (b)(6) 2022 and explant on (b)(6) 2022.510k: this report is for an unknown fns antirotation nail head element/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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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Search Alerts/Recalls
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