Model Number 1516-40-608 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Pain (1994)
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Event Date 09/06/2017 |
Event Type
Injury
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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.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant med products: attune fb tib base sz 6 cem knee tibial tray component; unknown knee femur component; attune ps fb insrt sz 6 8mm knee tibial insert component; unknown knee patella component; unknown bone cement.Initial reporter occupation: non-healthcare professional ¿ attorney.
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Event Description
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Complaint description: the patient was revised to address loosening of the femoral and tibial components at the bone to cement interface, depuy cement was used.Der indicates that patient was done by spiegler using trumatch attune.Patient was at vcu complaining of knee pain.X-rays done show both femoral and tibial loosening at the bone to cement interface, depuy cement was used.The surgeon said this is an overall loosening, not a debonding issue.
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Manufacturer Narrative
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(b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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).No device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : null.Device history batch : null.Device history review : null.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. .
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary update 22-jan-2021: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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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