Catalog Number 150410208 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
Unspecified Infection (1930)
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Event Date 12/11/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 was revised to address infection and loosening of unknown component at cement to implant interface.Surgeon removed all implants and placed static abx spacer.Doi: (b)(6) 2016, dor: (b)(6) 2017, unknown affected side.
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Manufacturer Narrative
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Please disregard this medwatch submission as it was reported in error.It is not reasonable to conclude that the device contributed to the patient's infection, 1 year after implantation.It's reasonable to conclude the implant isn't the subject of the reported serious injury of loosening ¿ tibial component.
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Event Description
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Loosening of tibial component and infection.
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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.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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Search Alerts/Recalls
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