Model Number 42-0907 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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 as " event descriptions: tmk23137, kk, not enough external rotation in surgery.Tmk23228, mt, too much external rotation in surgery.Tmk23258, jg, left knee, following up on rotation issue.".
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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.Review of the design files confirmed the reported, and corrective action was implemented.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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 (b)(4) 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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