Model Number 02.12.0610FL |
Device Problems
Material Rupture (1546); Appropriate Term/Code Not Available (3191)
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Patient Problem
Pain (1994)
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Event Date 10/23/2020 |
Event Type
Injury
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Manufacturer Narrative
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Batch review performed on 03 november 2020: lot 1908781: (b)(4) items manufactured and released on 22-nov-2019.Expiration date: 2024-11-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
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Event Description
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The patient came in reporting pain due to a ruptured arthrotomy, 2 months after primary surgery.The cause of the ruptured arthrotomy is unknown.The surgeon revised the gmk-sphere tibial insert - flex s6l - 10 mm with a gmk-sphere tibial insert - flex s6l - 10 mm.The surgery was completed successfully.
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Search Alerts/Recalls
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