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Catalog Number 09.402.020S |
Device Problem
Unintended Movement (3026)
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Patient Problems
Pain (1994); Non-union Bone Fracture (2369)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 manufacture date is unknown.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 the patient was originally implanted with a 7mm curved radial stem implant and a 20mm radial head implant on (b)(6) 2016 for a fractured proximal ulna.Reason for fracture is unknown.Patient presented with pain and a non-union.Also, the surgeon observed thru images on an unknown date the implant was loose.A follow up procedure was performed on (b)(6) 2017.Both implants were removed.Patient was not revised to any other implants.The removed implants were observed to be in good condition.No fragments were generated during the explant.Patient is reported in stable condition and the explant surgery was completed successfully.This is report 1 of 2 for (b)(4).
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Manufacturer Narrative
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Complaint was reviewed and determined to be a part of recall updated.Corrected data: manufacture site.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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Search Alerts/Recalls
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