Model Number 1516-40-410 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Joint Laxity (4526)
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Event Date 01/08/2021 |
Event Type
Injury
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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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Event Description
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The patient was revised to address mcl loosening.Poly size increased for stability.No implant loosening reported.Doi: (b)(6) 2018, dor: (b)(6) 2021, 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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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