Catalog Number UNK ATTUNE KNEE TIBIAL TRAY |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Discomfort (2330); No Code Available (3191)
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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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Attune knee claim record received.Claim record alleges pain, discomfort, instability, difficulty ambulating, mental suffering and aseptic loosening of the tibial tray.Unknown cement was used.Doi: (b)(6) 2014, dor: planned, right knee.
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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 device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.H10 additional narrative: added: h6 patient code: no code available (3191) used to capture the emotional distress.
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Search Alerts/Recalls
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