Catalog Number 151650405 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Date 02/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).
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Event Description
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The patient was revised to address suspected loosening and painful knee.Femur was not grossly loose.Tibia was not grossly loose, however, once removed it was found to have no cement adherence.Femur and tibia were removed and revised to a sigma tc3/mbt rev combination.No further patient information is available.Doi: (b)(6) 2018; dor: (b)(6) 2019; left knee.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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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Search Alerts/Recalls
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