Catalog Number 167061F |
Device Problem
Noise, Audible (3273)
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Patient Problem
Joint Laxity (4526)
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Event Date 11/12/2020 |
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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Delta motion cup and head exchange to treat noise and joint instability secondary to impingement.Surgeon implanted a competitor cup and ceramic ts head.
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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.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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Event Description
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We would like to confirm if the liner was also revised, if yes, kindly provide the part and lot of liner and cup.Response: delta motion cup, is inclusive of the liner, it is a one-piece system, there is no separate product code.
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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 worldwide complaint search was performed for complaints received since 01 jan 2015, due to the limitations of the complaint database search tool.No additional previous reports against the provided product code/lot code combination were found.However, since the current product/lot combination was manufactured prior to 01 jan 2015 the results of the search are inconclusive.Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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