Catalog Number 102452300 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Discomfort (2330)
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Event Date 01/01/2014 |
Event Type
Injury
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Event Description
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The patient had a primary knee surgery, initial recovery hampered by lateral discomfort ¿ arthroscope in 2014.This complaint is linked to (b)(4) - captured the event poly worn.
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Manufacturer Narrative
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Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: g4 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d1, d2, d4 and d10.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for examination.Available x-rays were reviewed.Reported condition is not confirmed.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.
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Search Alerts/Recalls
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