Model Number 1554-02-121 |
Device Problem
Fracture (1260)
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Patient Problems
Inflammation (1932); Pain (1994)
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Event Date 11/23/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient was presented with mid thigh pain.X-rays showed a fracture in the stem roughy where the flange begins.Patient says no trauma occurred, was walking around on vacation.After re-examining x-rays from 2018, it appears there may have been the beginning of a fracture.At the time, patient presented with bursitis symptoms.Current x-rays show remodeling lateral to the stem fracture.No sign of infection.No surgical delay was reported.Doi: (b)(6) 2008.Dor: (b)(6) 2022.Affected side: left.
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Manufacturer Narrative
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Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.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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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 manufacturing record evaluation (mre), was not possible because the provided lot code was not valid.
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Search Alerts/Recalls
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