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Device Problem
Unintended Movement (3026)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).The complaint indicated that the radial stem loosened post-op requiring additional surgical intervention.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 a patient had a loose radial stem implant.A revision surgery took place on (b)(6) 2017.It is unknown how the implant loosening was discovered.The implants were explanted intact with no issues during the revision.It is not known if the patient was revised with new hardware.There was no time delay.The patient's outcome is unknown.No additional information.This complaint involves (1) part concomitant device reported: (1) radial head (part # unknown, lot # unknown), 2 unknown items (part # unknown, lot # unknown) this report is 1 of 1 for (b)(4).
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Search Alerts/Recalls
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