Model Number 1365-36-320 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Swelling (2091); Tissue Damage (2104); No Code Available (3191)
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Event Date 12/14/2016 |
Event Type
Injury
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Manufacturer Narrative
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(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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The patient was subjected to 2 surgical procedures of hip arthroplasty (left and right): the first one on (b)(6) 2009 and the second one on (b)(6) 2009.Immediately the patient started to accuse pain at hip, headache , general weakness and affordable breathing.During (b)(6) 2016, due to the aggravation of the symptoms in addition to fever and painful tumefection, went to (b)(6) hospital in which was diagnosed periprosthetic abscess.The patient was so subjected to washing and drainage and pharmacological therapy.
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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.
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Search Alerts/Recalls
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