Catalog Number 3105040 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bradycardia (1751); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); No Code Available (3191)
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Event Date 07/16/2020 |
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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Allergy.This case is from the health authority.It was reported that the patient suffered from symptoms of low heart rate, low blood pressure, and decreased blood oxygen after using the bone cement product in the surgery of left hip arthroplasty.It was thought that the patient was allergic to the bone cement.Immediate rescue measures such as pressor, volume expansion and anti-shock were used.Then the patient's heart rate rose, blood pressure returned to normal, blood pressure saturation was acceptable.All vital signs were basically stable and sent to department of internal medicine for observation and treatment.
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Manufacturer Narrative
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Product complaint # (b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.
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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: details for gentamicin component of combination product: dmf# - 13704, trade name ¿ gentamicin sulphate, active ingredient(s) ¿ gentamicin sulphate, dosage form - powder, strength ¿ 1.0g active in our cements.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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Search Alerts/Recalls
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