Model Number 1516-20-507 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 06/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.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 left knee revision to treat a flexion contracture of 5 degrees.Upon entering the joint, the surgeon evacuated a small effusion and debrided periarticular synovitis.The tibial tray was grossly loose and easily removed.The surgeon excised cystic lesion from the underlying tibial bone.The femoral component was well fixed but revised.There was no reported product problem with the revised tibial insert.The patella was well fixed and retained.The patient was revised with competitor products.The procedure was completed without complications.Doi: (b)(6) 2014.Doe: (b)(6) 2014.(mua, no revision, captured in (b)(4)).Dor: (b)(6) 2020.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.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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