Model Number 5450-35-500 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Adhesion(s) (1695); Edema (1820); Pain (1994); Burning Sensation (2146); No Code Available (3191); Joint Laxity (4526); Swelling/ Edema (4577)
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Event Date 06/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.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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The patient had left knee arthroplasty, from the date forward had issues with knee swelling, redness pain and severe burning sensation.Patient readmitted to the hospital.On 2017 orthopedic surgeon again as was thought to be an infection in the knee.All cultures were negative for infection.Doi: (b)(6) 2017; dor: (b)(6) 2017; left knee.
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Manufacturer Narrative
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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.Patient code: no code available (3191) was used to capture joint laxity.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : device history review completed 12 dec 18.1 unrelated non-conformance on this lot number.Final micro and sterility tests passed.
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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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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