Catalog Number 136552000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Swelling (2091); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Test Result (2695)
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Event Date 12/11/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(6).
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Event Description
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Litigation alleges that the patient suffered from severe pain, discomfort, swelling in his legs, difficulty ambulating, suffering, severe and possibly permanent injuries, emotional distress, disability and disfigurement.Doi: (b)(6) 2006.Dor: scheduled on (b)(6) 2018; left hip.
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Manufacturer Narrative
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(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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Der received confirming revision surgery occured.
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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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