Date of post-operative loosening of the stem is unknown.This report is for one (1) unknown radial stem.Part and lot numbers are unknown.Without the part and lot number, the udi is not available.Unknown if the patient has been revised.Complainant device 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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