Catalog Number 150611003 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 02/25/2019 |
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 pain, discomfort and loosening of the tibial component at the bone to implant interface.The x-rays showed slight radiolucency on the tibial component.The surgeon opened up the knee and saw a bit of micro motion so the poly and tibia were replaced.Doi: (b)(6) 2018; dor: (b)(6) 2019; right 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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