Catalog Number UNK HIP ACETABULAR CUP |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Pain (1994); Discomfort (2330); No Code Available (3191)
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Event Date 04/11/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Occupation: lawyer.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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After review of medical records, patient was revised to addressed left hip arthroplasty, disassociation.Operatives notes indicated discomfort, pain and squeaking.Doi: (b)(6) 2017; dor: (b)(6) 2018; left hip.
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Manufacturer Narrative
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H10 additional narrative: product complaint # = > pc-(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.Device history lot = > null.Device history batch = > null.Device history review = > null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. h10 additional narrative: 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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Search Alerts/Recalls
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