Model Number 1365-36-320 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Sepsis (2067); Swelling (2091); Discomfort (2330); No Code Available (3191)
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Event Date 11/10/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.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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After review of medical record, patient was revised to address infection.Revision notes stated that a large amount of fluid was seen within subcutaneous space.Patient underwent an irrigation and debridement of the left wound and large vac application.Patient experienced pain, swelling, tenderness, active rom moderately impaired, and severe sepsis.Doi: (b)(6) 2016, (head,liner,stem).Doi: (b)(6) 2016, (cup, screw, apex).Dor: (b)(6) 2016, left hip.
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Manufacturer Narrative
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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.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, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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