Model Number 5450-50-501 |
Device Problems
Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Joint Contracture (4528)
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Event Date 05/16/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Dmf# - (b)(4), 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 due to infection.Date of implant: (b)(6) 2020.Date of revision: (b)(6) 2022.Left knee.Femoral component, tibial component, insert, and patella were removed.
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Event Description
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Medical records received: primary operative notes (b)(6) 2020 indicate the patient received a left total knee replacement due to osteoarthritis.The surgery was completed without indication of complication by the surgeon.Revision operative notes (b)(6)) 2022 indicate the patient received a left total knee revision due to infection.Upon entering the joint, an abscess, joint contracture, and scarring was encountered and removed to the best ability.The femoral component was noted to be loose at an unknown interface.The surgery was completed without indication of complication by the surgeon.Operative notes (b)(6) 2022 indicate the patient received a stage 2 of 2 re-implantation as the infection had cleared.
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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.Update received on 27-july-2021 did not have any additional details to be added in investigation.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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