Model Number 5450-50-501 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
Adhesion(s) (1695)
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Event Date 03/29/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.Dmf# - (b)(4), trade name gentamicin sulphate, active ingredient(s) (b)(4), dosage form - powder, strength 1.0g active in our cements.Component code: appropriate term/code not available (g07002) used to capture no findings available.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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Event Description
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Female patient received a left attune primary tka to treat end-stage osteoarthritis.The patella was resurfaced and depuy cement x1 was utilized.The procedure was completed without complications.54-year-old female patient received a left knee revision to treat tibial tray loosening.Upon entering the joint, significant periarticular scar tissue was debrided.The tibial tray was loosened at the cement to implant interface and revised.There was no reported product problem with the revised tibial insert.The femoral component and patella were retained.The patient received an attune revision construct.The procedure was completed without complications.Doi: (b)(6) 2018, dor: (b)(6) 2019, left knee.
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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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (nc search) was performed for the finished device product code - 545050501, lot number -8539210, and no non-conformances / manufacturing irregularities were identified.
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Search Alerts/Recalls
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