Model Number 5450-35-500 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Muscular Rigidity (1968); Pain (1994); No Code Available (3191)
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Event Date 01/14/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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Event Description
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Patient was revised to address loosening of the tibial component at cement to implant interface.
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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.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Medical records received on 17 jun 2019 were reviewed to identify patient harms/product issues on (b)(6)2019.The patient underwent a left knee revision due to pain, stiffness, osteolysis, and tibial tray loosening at the cement to implant interface.The femoral component and patella component were not revised.Two depuy cement products were used during the primary operation.Doi: (b)(6)2014.Dor: (b)(6)2019 left knee.
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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.Additional narrative: added: age , description of event or problem, device identification, medical products & therapy dates, evaluation codes (no code available (3191) is used to capture the medical device removal).Corrected: patient identifier.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.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Initial reporter occupation: lawyer.
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Search Alerts/Recalls
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