Catalog Number 3095040 |
Device Problem
Expiration Date Error (2528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/06/2022 |
Event Type
malfunction
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Event Description
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The product which is past is expiration date was used to cement the prosthesis into a patient.The theatre team at the hospital noticed the product was outside of the expiration date 4 minutes into mixing and cementing process and alerted the surgeon.The surgeon decided to proceed with cementing as at this point the cement had already been applied to the patient and had been impacted into the patient and didn¿t want to risk potentially harming them by removing the prosthesis.I was alerted after the incident, as they wished to know of any potential adverse effects to the patient.I directed them to the information sheet provided with the cement although this does not explicitly indicate any potential adverse outcomes.
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Manufacturer Narrative
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Product complaint : (b)(4).Dmf# - 13704 trade name gentamicin sulphate active ingredient(s) gentamicin sulphate dosage form - powder strength 1.0g active in our cements.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 (nc search) was performed for the finished device 3095040, lot 9448048, and no non-conformances / manufacturing irregularities were identified.
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Search Alerts/Recalls
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