Catalog Number 151640806 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Code Available (3191)
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Event Date 09/12/2017 |
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 a left attune tka utilizing depuy cement on (b)(6) 2013.She was revised on (b)(6) 2017 for aseptic loosening of the tibial and femoral component utilizing a competitor¿s system.Surgeon notes significant inflammatory response synovitis requiring removal.Patellar component was not revised.Surgeon notes the femoral component was slightly loose and tibial component was frankly loose.Loosening interface was not provided.Doi: (b)(6) 2013; dor: (b)(6) 2017.
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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.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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This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
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Search Alerts/Recalls
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