Device was used for treatment, not diagnosis.This report is for unknown radial head/unknown lot number.Device is not expected to be returned for manufacturer review/investigation.(b)(4) patient experienced a severe lucency of the radial head prosthesis (head and stem) as well as a fracture of the surrounding cortex.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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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