Model Number EFSRNXXX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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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 event will be updated once the investigation is complete.Trends will be evaluated.
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Event Description
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Allegedly, a study by (b)(6) et al reported 2 unrevised cases of "soft tissue infection" in patients implanted with an evolution primary knee.
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Manufacturer Narrative
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10.Additional information received on (b)(6) 2021.Adverse events reported in the article are not medical device related, as clarified by dr.(b)(6) in saudi arabia (author of the article and owner of the study) please void the report.11.Corrected data: event not reportable.
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Search Alerts/Recalls
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