SYNTHES USA 20MM COCR RADIAL HEAD STANDARD HEIGHT/12.0MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
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Catalog Number 09.402.020S |
Device Problem
Unintended Movement (3026)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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This device was used for treatment, not diagnosis.Date of event: unknown.(b)(4) lot number unknown.Explant date: unknown.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.An image reading of the x-rays was conducted by a medical director from this manufacturer.The medical director says, it appears there is a relative low density zone around the implant but cannot comment too much due to lack of quality and information.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 was implanted with radial head prosthesis system on (b)(6) 2015 for a radial head fracture.Postoperatively, after around 4-5 months, x-rays were taken on an unknown date and it was discovered that the construct had loosened in the radial medullary canal.The revision surgery was performed on an unknown date.The patient's outcome is unknown and it is unknown if the patient was treated with a new construct.This report is 2 of 2 for (b)(4).
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Search Alerts/Recalls
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