Model Number 1504-10-205 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Fibrosis (3167); No Code Available (3191)
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Event Date 03/06/2019 |
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 was revised to address pain and ortho fibrosis.Doi: (b)(6) 2017; dor: (b)(6) 2019, right knee.
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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 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: 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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Event Description
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(b)(6) 2017: patient had right knee replacement due to arthritis.Depuy implants were placed with depuy cement (qty.1).There were no intra-operative complications.(b)(6)2019: patient underwent a right knee revision due to pain.The tibial tray and femoral component were thought to be loose pre-op.During the operation the femoral component was noted to be well fixed, but revised.The tibial tray didn't appear to be loose, however using a thin blade osteotome the tibial component was removed with all of the cement adhering to the bone and nothing to the tibial prosthesis.The patella was noted to be well fixed and the correct fit.Attune revision implants were placed with depuy cement.
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Manufacturer Narrative
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Patient code: no code available (3191) used to capture the device revision or replacement.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 : 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.
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Search Alerts/Recalls
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