Model Number 3L93709 |
Device Problem
Migration (4003)
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Patient Problems
Pain (1994); Insufficient Information (4580)
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Event Date 05/04/2021 |
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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Right hip stem collapsed into varus and needed to be revised.Original dos (b)(6) 2020.
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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 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 (mre) review, was not possible because the required lot code was not provided.
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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 and h6 (patient).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d3 and g1.
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Event Description
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Questions: a.Was there a surgical delay during the revision surgery? if yes, what was the duration of the delay? b.Was the patient experiencing any adverse symptoms that led to the revision surgery? answers for your questions: patient was revised due to painful total hip.There was no surgical delay.
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Search Alerts/Recalls
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