Catalog Number 151810032 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Date 03/07/2019 |
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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Patient was revised to address pain and loosening of the tibial component at the cement to implant interface.Cement manufacturer is unknown.Revision of patella was done.Surgeon thought the patella was too thick.Femur remains insitu 150410104/hd7043.Doi: (b)(6) 2017 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, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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