Catalog Number UNK HIP ACETABULAR LINER |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problems
Pain (1994); Scar Tissue (2060); Test Result (2695); No Code Available (3191)
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Event Date 10/17/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter 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 claim and medical records, it was stated that the patient was revised to address pain, removal of metal on metal articulation and eliminate metal ion production.Operative notes indicate that the fascia was scarred, approximately 100-150 ml of turbid fluid was found in the joint and there was a minor amount of corrosion at the trunnion.(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, post market surveillance, 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.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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