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Model Number EQUINOXE REVERSE 38MM GLENOSPHERE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 12/08/2023 |
Event Type
Injury
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Event Description
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It was reported that a 65 yo male patient, initial left shoulder implanted on (b)(6) 2023, underwent a revision procedure on (b)(6) 2023.The patient was revised due to infection.The glenosphere, liner and adapter tray were revised.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays or device images were able to be obtained.The explanted devices are not available for analysis as they were disposed of by the hospital.No further information.
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Manufacturer Narrative
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D10: concomitants: (b)(6)- 300-01-07 - equinoxe, humeral stem primary, press fit 7mm.(b)(6)- 315-35-00 - glnd kwire.(b)(6)- 320-01-38 - equinoxe reverse 38mm glenosphere.(b)(6)- 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6)- 320-15-03 - rs glenoid plate post aug, 8 deg, left.(b)(6)- 320-15-05 - eq rev locking screw.(b)(6)- 320-20-00 - eq reverse torque defining screw kit.(b)(6)- 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.(b)(6)- 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6)- 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6)- 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm (b)(6)- 320-38-00 - equinoxe reverse 38mm humeral liner +0.(b)(6)- 31-20-00 - shldr gps rvrs drill kit.(b)(6)- 531-78-20 - shouldr gps hex pins kit.4000523050 ¿ (b)(6)- gps implant kit v2.Additional information, including the product investigation, will be submitted within 30 days of receipt.
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Manufacturer Narrative
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The glenosphere, liner and adapter tray were appropriately released for distribution.The reason for the patient's infection and subsequent revision procedure as related to the devices cannot be conclusively determined.There was no medical or clinical information provided.These devices are used for treatment not diagnosis.
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Search Alerts/Recalls
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