Catalog Number 111517000 |
Device Problem
Naturally Worn (2988)
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Patient Problem
No Code Available (3191)
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Event Date 01/01/2020 |
Event Type
Injury
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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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Polyethylene wear was reported.Implanted in 2005.
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Event Description
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Additional information received that this was a first revision case.No surgical delay and left side was involved in this event.
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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.Patient code: removed code for absence of treatment and replaced with no code available (3191) to capture device revision or replacement.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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Although not returned poly material wear would not be unreasonable after approximately 15 years implanted.The information received will be retained for potential series investigations if triggered by trend analysis 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 history record (dhr) review, was not possible because the required lot code was not provided.
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Search Alerts/Recalls
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