Catalog Number 253092000 |
Device Problems
Device Damaged Prior to Use (2284); Naturally Worn (2988)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/29/2021 |
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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It was reported for a damaged head.There was no surgical impact or delay.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, d6a.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: b3, h6 medical device problem code.
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Event Description
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Additional information received confirmed that it was worn and the surgery's time wasn¿t extended.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: update 02-feb-2022.No device was received for examination, therefore the reported event could not be confirmed.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: manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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Search Alerts/Recalls
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