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Device Problem
Unintended Movement (3026)
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Patient Problems
Failure of Implant (1924); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Device used for treatment, not diagnosis.Patient information not available for reporting.Udi: part number unknown, lot number unknown, udi unavailable.This report is for unknown unk - radial stem/unknown lot number.Original implant date is unknown.Device is not expected to be returned for manufacturer review/investigation.It was reported that the radial stem was loosening postoperatively which required removal.No new hardware was implanted.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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Event Description
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It was reported that patient went through radial head prosthesis on unknown date.On unknown date, patient had removal of radial head prosthesis revision surgery due to stem loosening.Radial head and stem were removed without delay and procedure was completed successfully.No new hardware was implanted.Patient is reported as stable.This complaint involves one device.This event is for second patient.The events for patient 1 and 3 are covered under (b)(4) respectively.Concomitant devices reported: radial head (part # unknown, lot # unknown, quantity # 1).This report is 1 of 1 for (b)(4).
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Search Alerts/Recalls
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