Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Degraded (1153)
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Patient Problems
Pain (1994); Test Result (2695); No Code Available (3191)
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Event Date 06/12/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (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 there was a revision of asr due to pain, high ion levels, galvanic corrosion trunion.Doi: (b)(6) 2007; dor: (b)(6) 2020; affected side: right hip.
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Manufacturer Narrative
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Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate corrected: h6 (device).Removed: test result.No code available (3191) is used to capture blood heavy metal increased.
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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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