Catalog Number 121881752 |
Device Problems
Fracture (1260); Difficult to Open or Remove Packaging Material (2922)
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Patient Problems
Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 08/28/2020 |
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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Fractured ceramic liner.
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Event Description
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Affected side: left.Additional information supplied by andrew herbert: it should be further noted that subsequently the surgeon has commented to me that most likely the ceramic liner was either not correctly seated by him or not appreciated as being mal-positioned by him at the primary surgery.He felt that this was the most likely cause for the liner fracture.
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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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A review of the device manufacturing records found no related deviations or anomalies.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 : 9165669.
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Search Alerts/Recalls
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