Model Number 1547-07-001 |
Device Problems
Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Pain (1994); No Code Available (3191)
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Event Date 09/14/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant medical products: atune rev rp tib base sz 6 cem knee tibial tray component; attune crs femoral lt sz 7 cem knee femur component; attune crs rp insrt sz 7 6mm knee tibial insert component; unknown knee patella component; smartset gmv 40g us eo bone cement; atun tib slv m/l 37mm full por knee tibial tray component; atune pressfit str stem12x60mm knee tibial tray component; attune pos fem aug sz 7 4mm knee femur component x 2; attune dist fem aug sz 7 4mm knee femur component x 2; attun rev offst stm adptr 4mm knee femur component; attune pressfit str stem16x60mm knee femur component.(b)(4).
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Event Description
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Subject id: (b)(6).Clinical adverse event received for infected left total knee arthroplasty.Event is serious and is considered moderate in severity.Event is not related to device and is possibly related to procedure.Doi: (b)(6) 2018; doe:(b)(6) 2018.Patient hospitalized for treatment, event is ongoing; left knee.
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Manufacturer Narrative
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Product complaint #: (b)(4).This medwatch report was created in error.There was no reportable product deficiency.Please disregard the previously reported content.
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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 new information provided states that the infection adverse event was treated with an irrigation & debridement, with revision of components, as well as iv medications.It should be noted that the implant procedure for these products took place on (b)(6) 2018, which appears to have been the re-implantation of products, following explantation of antibiotic spacer for deep infection.There is no information available with regard to the original knee infection, date of primary and first revision, and products involved.
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. corrected: (no code available (3191) is used to capture the device revision or replacement).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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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate. .
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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.
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Search Alerts/Recalls
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