Catalog Number 136550100 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Discomfort (2330); Deformity/ Disfigurement (2360); Test Result (2695); No Code Available (3191)
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Event Date 10/11/2017 |
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.(b)(4).(b)(6).
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Event Description
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Litigation alleged severe pain interfered with patient's daily activities, discomfort, high levels of cobalt and chromium, emotional distress, and disfigurement.
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Manufacturer Narrative
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(b)(4).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.
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Search Alerts/Recalls
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