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Catalog Number H3-82846 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/15/2019 |
Event Type
Injury
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Manufacturer Narrative
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The complainant made no indication of any omnilife science device malfunction or deficiency related to the identity, quality, durability, reliability, safety, effectiveness or device performance contributing to the adverse event.Review of the manufacturing documentation and sterilization documentation for the devices in question revealed no deviation from process or non-conformity of product that would have caused or contributed to the adverse event.
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Event Description
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A patient underwent a hip revision surgery on (b)(6) 2019.The original surgery is dated (b)(6) 2016.The reason for revision is unknown.During the revision, the original femoral head, stem, neck and bipolar head were removed and replaced with new non-omni components.
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Search Alerts/Recalls
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