Model Number 1506-11-003 |
Device Problems
Osseointegration Problem (3003); Migration (4003)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 05/03/2022 |
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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Primary surgery(b)(6) 2021.Revision of implant (b)(6) 2022 (left side) revision of a loose and subsided attune rp tibial base size 3 procoat.Revised to an attune tibial tray with a metaphyseal sleeve and steam attune ps femur was retained attune ps/rp insert was changed.
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Event Description
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Additional information received indicated that there was no surgical delay reported.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : the device associated with this complaint was not received for examination.The photo investigation cannot confirm the reported allegation, indicators of loosening cannot be seen on the evidence provided.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 : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.
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Search Alerts/Recalls
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