Model Number 42-0906 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/01/2021 |
Event Type
malfunction
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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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During bilateral tka, there was a major issue with the external rotation on both femoral blocks.The blocks were externally rotated.After noticing there was too much external rotation, surgeon had to use the regular sizing device to dial it back down to normal, delaying each knee by about 10 minutes.".
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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.No evidence was found indicating product error was a contributing factor to the reported event.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot : a device history record (dhr) review was performed.The review found one non-conformance (nr-0138283) against the provided lot number.The nr was for a batch of resin not meeting a material specification, and it is not related to the current reported event of too much external rotation in surgery.
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Search Alerts/Recalls
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