Model Number 5450-50-501 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 06/22/2021 |
Event Type
Injury
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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.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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Clinical notification received for revision of left total knee to address infection date of implantation: (b)(6) 2019.Date of revision: (b)(6) 2021.(left knee).Treatment: revision of all products (femur construct, tibial construct, insert, and patella components).
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Manufacturer Narrative
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Product complaint # (b)(4).
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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: added: a2 (date of birth) and b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d6a.
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Event Description
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Medical records received indicated that the primary operative notes and the first revision procedure notes were not provided within this set of medical records.It is unknown, at this time, what the manufacturer of the primary implants or first revision surgery were.Unknown if depuy ¿ dates of primary and first revision surgeries also not provided.Revision operative notes (b)(6) 2019 indicate the patient received a left total knee revision due to infection.It is unknown if depuy products were implanted at this surgery.Re-implantation operative notes (b)(6) 2019 indicate the patient received a left total knee re-implantation due to infection markers were satisfactory for re-implantation.The surgery was completed without indication of complication by the surgeon.Revision operative notes (b)(6) 2021 indicate the patient received a left total knee revision due to infection.The surgery was completed without indication of complication by the surgeon.((b)(4)) revision operative notes (b)(6) 2021 indicate the patient received a left total knee revision due to pain, swelling and hematogenous spread of infection.The surgery was completed without indication of complication by the surgeon.((b)(4)).
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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 the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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