Catalog Number 130770024 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 09/25/2019 |
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.
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Event Description
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1st stage revision shoulder arthroplasty.Approximately 9 month history of discomfort and reduced range of motion.Serum clinical markers, as stated by dr.Shepherd, indicated infection in prosthetic shoulder joint.All prosthesis removed.Humeral osteotomy required to removed well fixed stem.Multiple tissue specimens taken.Turbid fluid aspirated from joint prior to joint being opened.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary = > no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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