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Catalog Number 3332040 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problems
Unspecified Infection (1930); Pain (1994); Swelling (2091); Depression (2361); No Code Available (3191)
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Event Date 10/10/2018 |
Event Type
Injury
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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.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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Revision due to infection, pain, loosening of the femoral component at the bone to cement interface, pain, depression, and swelling.Doi: (b)(6) 2018; dor: (b)(6) 2018; (right knee).
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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.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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Search Alerts/Recalls
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