Model Number 1512-14-030 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Sepsis (2067); Dizziness (2194)
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Event Date 04/02/2023 |
Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2022, the primary surgery was performed via tka for oa with the implants in question.The surgery was completed successfully without any surgical delay.On (b)(6) 2023, the patient was rushed to the hospital in the morning due to dizziness, speech disturbance, and decreased level of consciousness because of suspected sepsis due to infection.With vitals back to normal, the patient was transferred to this facility, where a thorough examination was conducted and infection was confirmed.The revision surgery was performed on (b)(6) 2023, to remove all the implants and place the antibiotic cement mold.Also, drains were placed.The surgery was completed successfully without any surgical delay.The infection was caused by pus that had accumulated in the toe.History of diabetes mellitus.No further information is available.
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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.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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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Search Alerts/Recalls
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