Model Number 1506-10-005 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Thrombosis (2100); No Code Available (3191)
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Event Date 12/26/2017 |
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 an attune tka utilizing depuy cement.She then underwent a revision for loosening at the tibial base-cement interface.Intraoperatively, patient was found to have a dvt with evidence of an absent dorsalis pedis and posterior tibialis pulse requiring a vascular surgeon to perform a thrombectomy and greater saphenous vein patch angioplasty.Surgical delay time not noted.Doi: (b)(6) 2014, dor: (b)(6) 2017 (right).
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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 at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 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. additional narrative: udi:(b)(4).Added: patient identifier, date of event and other relevant history.
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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 at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Patient code: no code available (3191) was used to capture medical device removal.
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Search Alerts/Recalls
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