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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cellulitis (1768); Skin Inflammation/ Irritation (4545)
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Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown plates: metaphyseal/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient had a left proximal tibia periprosthetic fracture orif, pain, and cellulitis.Synthes distal metaphyseal tibial plate was used during this procedure.On (b)(6) 2021, the patient was noted to have wound breakdown with ¿metalware on show¿ and cellulitis.Patient is scheduled to have metal ware removed and a skin flap to cover defects¿ on an unknown date.The reported product was an unknown synthes distal metaphyseal tibial plate.This report is for one (1) unk - plates: metaphyseal.This is report 1 of 2 for (b)(4).
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Search Alerts/Recalls
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