Model Number 1504-10-108 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Joint Disorder (2373); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).
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Event Description
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Patient underwent bilateral attune tkas on (b)(6) 2014.He has had pain in bilateral knees since the primary surgery.Xrays suggest bilateral lucency below the tibial trays at both the bone to cement and cement to implant interface.He underwent a left revision only on (b)(6) 2017.Surgeon notes the femoral component was oversized and the tibial component was easily removed, leaving no cement on the bone.Patella was revised.Doi: (b)(6) 2014 dor: (b)(6) 2017, (left).
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Manufacturer Narrative
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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. patient code: no code available ((b)(4)) used to capture the surgical intervention and medical device removal.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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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.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.Device history lot: null.Device history batch: null.Device history review: null.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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