Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Test Result (2695); No Code Available (3191)
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Event Date 07/07/2020 |
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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It was reported that the asr cup and head, patient is experiencing pain and elevated blood metal ion levels.The initial surgery was performed in (b)(6), we have no patient records of the exact date of surgery.Patient does not speak english and thought the surgery date was correct.Doi: (b)(6) 2006, dor: (b)(6) 2020, right side.
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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.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
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Search Alerts/Recalls
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