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Model Number 350-01-04 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Failure of Implant (1924)
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Event Date 02/10/2022 |
Event Type
Injury
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Event Description
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As reported, approximately 9 months post op the initial left ankle replacement, this (b)(6) male patient's was experiencing pain in ankle, constant, localized to medial and anterior ankle.He also had increased swelling and redness but denies any new injuries, falls, infection.Ordered labs to rule out infection.Symptoms slightly improved.Follow-up will be based on labs.The outcome is continuing.The case report form indicates this event is definitely not related to devices and unlikely related to procedure.This event report was received through clinical data collection activities.
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Manufacturer Narrative
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Pending evaluation: concomitant device(s): 350-21-24, tibial insert fb sz 4 lt 8mm, 350-10-04, ankle sz 4 locking clip.
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Event Description
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As reported by exactech vantage total ankle study, approximately 9 months post op the initial left ankle replacement due to osteoarthritis, this 69 y/o severely obese male patient was experiencing pain in ankle, constant, localized to medial and anterior ankle.He also had increased swelling and redness but denies any new injuries, falls, infection.Ordered labs to rule out infection.Symptoms slightly improved.Follow-up will be based on labs.No previous surgery on involved surgery or arthroplasty on other side.
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Manufacturer Narrative
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Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of pain cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.Section h11: *the following sections have corrected information: (b5) as reported by exactech vantage total ankle study, approximately 9 months post op the initial left ankle replacement due to osteoarthritis, this 69 y/o severely obese male patient was experiencing pain in ankle, constant, localized to medial and anterior ankle.He also had increased swelling and redness but denies any new injuries, falls, infection.Ordered labs to rule out infection.Symptoms slightly improved.Follow-up will be based on labs.No previous surgery on involved surgery or arthroplasty on other side.
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Search Alerts/Recalls
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