Model Number 1506-00-004 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problems
Injury (2348); Not Applicable (3189); No Code Available (3191)
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Event Date 07/30/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (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 being revised for suspected loose tibial tray component.Attune tibial tray was found to be grossly loose with no cement adherence to the back of the implant.There was also pitting on the poly insert.Patient was revised to an attune fb revision tray and stem and a new 20 mm poly insert.Tibial tray loosening at the cement to implant interface.Cement is a depuy product.No further patient information available.Doi: (b)(6) 2015.Dor: (b)(6) 2018.Right knee.
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Manufacturer Narrative
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(b)(4).No device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Udi: (b)(4).(b)(4) was used to capture medical device removal.
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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.H10 additional narrative: corrected: b1, b2, h6 (patient).Patient code: no code available (3191) to capture surgical intervention.
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Search Alerts/Recalls
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