Model Number SIZE 1 LEFT |
Device Problem
Insufficient Information (3190)
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Patient Problem
Unspecified Infection (1930)
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Event Type
Injury
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Manufacturer Narrative
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This is the initial report submitted regarding this surgical event and medical device.
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Event Description
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Patient had infection after total ankle arthroplasty performed (b)(6) 2015.Dr.(b)(6) removed salto talaris tibial insert as a precaution and performed i&d & replaced old tibial insert with new tibial insert (b)(6) 2015 (see mfr report 3000931034-2015-00127).Dr.(b)(6) then went back to surgery with patient (b)(6) 2015 & removed all salto talaris components due to continuous infection.Antibiotic spacer was implanted into patient.
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Manufacturer Narrative
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Medical device is manufactured in accordance with our specifications.Root cause of reported event could not be confirmed.Known inherent risk of procedure, the link with the concerned device is highly improbable this is the final report submitted regarding this surgical event and medical device.Not returned to manufacturer.
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Event Description
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Patient had infection after total ankle arthroplasty performed (b)(6) 2015.Dr.(b)(6) removed salto talaris tibial insert as a precaution and performed i&d & replaced old tibial insert with new tibial insert (b)(6) 2015 (see mfr report 3000931034-2015-00127).Dr.(b)(6) then went back to surgery with patient (b)(6) 2015 & removed all salto talaris components due to continuous infection.Antibiotic spacer was implanted into patient.
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Search Alerts/Recalls
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