Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Test Result (2695); No Code Available (3191)
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Event Date 07/21/2020 |
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 due to painful, elevated ions, and large mass on his hip.Swapped the metal liner for a plastic one.Doi: 2004; dor: (b)(6) 2020; affected side: left hip.
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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 or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Patient code: removed code for device revision or replacement and replaced with no code available (3191) to capture surgical intervention.
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Search Alerts/Recalls
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