Model Number 1012-14-005 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/19/2019 |
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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It was reported that the surgeon tried to insert the real offset in question, but the offset of the stem was tightly attached, and the surgeon couldn¿t reduce it.Therefore, the surgeon used the different offset (tri-lock bps sz 0 hi offset) instead.The surgery was completed successfully within 30 minutes delay.No further information is available.Capa(b)(4) / local #(b)(4))has been created for this late report.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.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 information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot a device manufacturing records review was performed.No deviations or anomalies identified.Device history review a device manufacturing records review was performed.No deviations or anomalies identified.
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Search Alerts/Recalls
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