Model Number EIS4S12L |
Device Problems
Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/26/2021 |
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, component exchanged due to ligament loosening.The component eis4s12l , lot 1842498 was revised.Replacement of inserts.(b)(4).
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Search Alerts/Recalls
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