Catalog Number 190-31-09 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Code Available (3191)
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Event Date 12/03/2018 |
Event Type
Injury
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Manufacturer Narrative
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Pending evaluation.
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Event Description
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Index surgery: (b)(6) 2018.Revision due to loosening.
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Manufacturer Narrative
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Section h11: corrections made in the following section(s): (g4) date received by manufacturer in the initial report should have been (b)(6) 2018.
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Manufacturer Narrative
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The revision reported in experience was likely the result of aseptic (non-infected) loosening of the femoral stem or the bipolar head, which damaged the bond of the implant to the bone.
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Event Description
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Index surgery: (b)(6) 2018.Revision due to loosening.This is one of three products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-990, 1038671-2018-00991, and 1038671-2019-00992.
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Manufacturer Narrative
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Section h10: (h3): the engineering evaluation reported in the experience was likely the result of aseptic (non-infected) loosening of the femoral stem or the bipolar head, which damaged the bond of the implant to the bone.Section h11: corrections made in the following section(s): (d1) brand name, (d2) product code, (g1) mdr reporting contact name.
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Search Alerts/Recalls
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