Catalog Number UNK KNEE TIBIAL INSERT |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Not Applicable (3189)
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Event Date 05/17/2016 |
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.
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Event Description
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Reviewed medical records received on 14 may 2018.Left attune total knee revised to address pain and global knee instability.Revising surgeon debrided scar tissue medially and laterally from the knee joint, and exchanged the polyethylene insert for a thicker size.Also performed an it band release.Indicated that there was no evidence of implant loosening or malrotation/improper positioning of implants.No product/lot information available for primary implants or cement.Doi: (b)(6) 2014; dor: (b)(6) 2016; (left knee).
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Manufacturer Narrative
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Product complaint # = > pc-(b)(4).Investigation summary = > no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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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