Model Number 1516-50-405 |
Device Problems
Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 03/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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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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On (b)(6) 2018 medical records received.After review of the medical records for mdr reportability, the patient was revised due to infection with loosening of the tibial component at the implant to cement interface.Competitor cement was utilized in each of the previous surgeries.All components removed.Competitor product placed.Doi: unknown for tibia tray and femoral component (prior to (b)(6) 2017); doi: patella (b)(6) 2017; doi: insert (b)(6) 2018; dor: (b)(6) 2018 for all.
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Manufacturer Narrative
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Product complaint # = > pc-(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, 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 synthese considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative: added: g3.Corrected: h6 (device).
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Search Alerts/Recalls
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