Model Number 02.07.0326SCF |
Device Problem
Material Rupture (1546)
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Patient Problem
Muscle/Tendon Damage (4532)
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Event Date 11/05/2021 |
Event Type
Injury
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Manufacturer Narrative
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Batch review performed on 12 november 2021: lot 1904799: (b)(4) items manufactured and released on 5-lug-2019.Expiration date: 2024-08-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
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Event Description
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At 1 month after the last surgery, the patient came in reporting pain due to a quad tendon rupture and the cause of the quad tendon rupture is unknown.The surgeon performed a quad tendon repair and revised the liner.The surgery was completed successfully.The previous revision surgery was performed on (b)(6) 2021 due to a fall and patella bone rupture.The surgeon performed a patellectomy and retinaculum repair and revised the liner.
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Search Alerts/Recalls
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