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Device Problem
Unintended Movement (3026)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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510k: this report is for an unknown radial stem.Part and lot numbers are unknown; udi number is unknown.Device was not explanted.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) 2017, the patient went to the surgeon for a follow-up visit and an x-ray revealed that the radial stem was loosening.The devices remain implanted and it is unknown whether they will be explanted.The patient was initially implanted with the unknown radial head and stem on (b)(6) 2016.Concomitant devices reported: radial head (part number unknown, lot number unknown, quantity 1).This report is for one (1) unknown radial stem.This is report 1 of 1 for (b)(4).
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Search Alerts/Recalls
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