Model Number 2294-54-000 |
Device Problems
Device-Device Incompatibility (2919); Material Twisted/Bent (2981); Naturally Worn (2988)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(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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It was reported that during a complex knee using the tc3 and revision mbt system the sleeve trials are not connecting to the tray trials.Surgeon feels the set is worn out, too old and the trials need to be replaced.Requested all sizes to be replaced.
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Manufacturer Narrative
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Product complaint # : (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Search Alerts/Recalls
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