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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 01/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Event year is reported as 2020; however exact date of postoperative fracture displacement is unknown.510k: this report is for an unknown locking screw/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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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Event Description
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It was reported that on (b)(6) 2020, a patient underwent the femoral neck system (fns) explanation procedure as femoral neck collapsed requiring conversion to bi-polar hip.The patient was reported to fallen on a few times.The implant was taken out successfully, with no issues or delay, and subsequent revision surgery was completed successfully.There were two locking screws removed as well.Patient status is reported as successfully converted to bipolar hip.This report is for one (1) unknown locking screw.This is report 2 of 5 for complaint (b)(4).
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Search Alerts/Recalls
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