Model Number 1518-20-038 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Muscular Rigidity (1968); Joint Laxity (4526)
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Event Date 07/20/2021 |
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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Revision left total knee replacement.Removal of attune revision implants, (tibial sleeve was not removed), due to stiffness, instability.There was no extended surgical time.Surgeon stated the femoral implant was oversized.No deficiency with the product.
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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.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).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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