Catalog Number UNK ATTUNE KNEE PATELLA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 04/28/2022 |
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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Patient was revised due to chronic infection, attune knee was explanted and cement spacer used.There are no implants available for return, no deficiency with the product, and no additional information to provide.Lot number for femur unknown, numbers/size of patella also unknown.There was no loosening and surgical delay.Doi: unknown.Dor: (b)(6) 2022.Affected side: unknown 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.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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Search Alerts/Recalls
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