Model Number 5450-35-500 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Synovitis (2094); Joint Disorder (2373); No Code Available (3191)
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Event Date 11/15/2016 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).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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Patient received a right primary attune to treat pain secondary to severe tricompartmental osteoarthritis.The patella was resurfaced and unknown cement x 2 was utilized.The procedure was completed without complications.Patient received a right knee attune revision to treat pain and arthrofibrosis secondary severe plastic induced synovitis of the knee.Upon entering the joint, the surgeon excised arthrosis and extensive synovitis.The tibial tray was grossly loose at the cement to implant interface and removed.The femoral component was well-fixed but revised.The patella was well-fixed and retained.There was no reported product problem with the explanted tibial insert.The patient was revised with a competitor construct.The procedure was completed without complications.Doi: (b)(6) 2015, dor: (b)(6) 2016, right 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.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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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: details for gentamicin component of combination product: dmf# - (b)(4); trade name ¿ gentamicin sulphate; active ingredient(s) ¿ gentamicin sulphate; dosage form - powder; strength ¿ 1.0g active in our cements.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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