Model Number 1035-48-000 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/13/2021 |
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 that when the packaging of the implant was opened, there was several black particles in the packaging and on the implant.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : examination of the returned device confirmed the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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 : no anomalies or deviations were found.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : examination of the returned device confirmed the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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 : no anomalies or deviations were found.
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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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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