Model Number 96-0008 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Pneumonia (2011)
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Event Date 01/01/2022 |
Event Type
Injury
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Event Description
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On (b)(6) 2022 the patient had a left total cemented knee arthroplasty to address end-stage arthrosis.Depuy components, including depuy patella and depuy cement were used during this procedure.08/16/2022 medical records note the patient is status post left knee replacement with new onset pain and popping.Initial surgery was 5 months ago, then the patient was septic postoperatively and pneumonia as well as c.Difficile.It was noted on physical examination that the patient has lots of valgus laxity.The impression is that the patient has status post left knee replacement with mcl injury and likely spinning out of poly.
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Manufacturer Narrative
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Product complaint # (b)(4).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 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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