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Catalog Number 320-10-00 |
Device Problems
Contamination (1120); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Joint Disorder (2373); No Code Available (3191)
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Event Date 04/27/2018 |
Event Type
Injury
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Manufacturer Narrative
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Pending evaluation.
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Event Description
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Index surgery: (b)(6) 2018.Revision due to infection.
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Event Description
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It was reported that a patient received a total shoulder implant on (b)(6) 2018.The patient was revised on (b)(6) 2018 after an infection was diagnosed at the 4-week postop visit.The patient was stable leaving the operating room.The devices were kept by the hospital and sent to pathology.This is one of ten products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00366, 1038671-2018-00367, 1038671-2018-00368, 1038671-2018-00370, 1038671-2018-00371, 1038671-2018-00372, 1038671-2018-00373, 1038671-2018-00374 and 1038671-2018-00375.
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Manufacturer Narrative
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After further review of additional information received the following sections b4, b5, d4, g3, g4, g5, g7, h2, h4 and h6 have been updated accordingly.This device is used for treatment not diagnosis.
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Search Alerts/Recalls
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