Model Number EFSRNXXX |
Device Problem
Fracture (1260)
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Patient Problem
Bone Fracture(s) (1870)
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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 al juhani et al reported 2 unrevised cases of "periprosthetic fractures" in patients implanted with an evolution primary knee.First event was captured under manufacturer reference number (b)(4).
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Manufacturer Narrative
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10.Additional information received on 16-aug-2021.Adverse events reported in the article are not medical device related, as clarified by dr.(b)(6) (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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