Catalog Number 121887354 |
Device Problems
Material Disintegration (1177); Naturally Worn (2988); Insufficient Information (3190)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); No Code Available (3191)
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Event Date 01/25/2018 |
Event Type
Injury
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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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Patient was revised to address pain.Metal insert replaced with a +4/36 poly and changed the head ball.Stem trunnion looked fine, surrounding tissue looked good.Put back in 1221-36-454 (+4 neutral liner) & 1365-52-000 m-spec 36 femoral head +5.Doi: 8 years ago; dor: (b)(6) 2018; unknown side.No surgical delay.
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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.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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Manufacturer Narrative
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(b)(4).
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Event Description
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Updated doi.Added lawyer in the associated contact.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Ppf alleges metal wear/metallosis and elevated metal ions.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: 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.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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Search Alerts/Recalls
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