Model Number 15-8521/30 |
Device Problems
Off-Label Use (1494); Detachment of Device or Device Component (2907)
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Patient Problems
Failure of Implant (1924); Insufficient Information (4580)
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Event Date 03/24/2023 |
Event Type
malfunction
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Event Description
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During a subsequent revision (date unknown) for tibial loosening the femoral component came loose from the taper.Surgeon knocked it back on and it's been ok thus far.
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Manufacturer Narrative
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The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.
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Event Description
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During a subsequent revision (date unknown) for tibial loosening the femoral component came loose from the taper.Surgeon knocked it back on and it's been ok thus far.[customer].
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Manufacturer Narrative
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The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.
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Search Alerts/Recalls
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