Catalog Number 150600005 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/02/2017 |
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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Der states that attune tibial tray was loosened, surgeon was able to extract the implanted attune tibia and pick away the cement and revise the tibia to an attune tibial revision.The femur was left in place.Loosening occurred from cement to implant interface.Cement manufacture is of competitor.(b)(6) 2015.(b)(6) 2017.Right knee.
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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.
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Manufacturer Narrative
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(b)(4).The received device was forwarded to commercialized product development for evaluation.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A definitive root cause of the reported event is unknown.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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Search Alerts/Recalls
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