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Catalog Number 320-38-10 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Joint Laxity (4526)
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Event Date 10/31/2023 |
Event Type
Injury
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Event Description
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It was reported that a 68 yo male patient, initial left shoulder implanted on (b)(6) 2018, underwent a revision procedure on october 31, 2023.The patient¿s tray and poly were revised due to instability.The xray showed the tray right up against the glenosphere, (metal on metal), so the poly had become dislodged.The +0 tray and 38mm +0 constrained liner were swapped for a new +0 tray with a 38mm +2.5 constrained liner.There were no device breakages or surgical delays.The patient was last known to be in stable condition following the event.X-rays were unable to be obtained.The explanted devices are not able to be returned as the hospital does not allow it.Device images were provided.No further information.
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Manufacturer Narrative
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D10: concomitants: (b)(6) 320-15-06 - rs glenoid plate ext cag +10mm cage peg (b)(6) 320-15-05 - eq rev locking screw (b)(6) 320-38-00 - equinoxe reverse 38mm humeral liner +0 (b)(6) 321-20-00 - equinoxe reverse shoulder drill kit (b)(6) 315-35-00 - glnd kwire 5251874 315-35-00 - glnd kwire (b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0 (b)(6) 320-01-38 - equinoxe reverse 38mm glenosphere (b)(6) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6) 320-15-05 - eq rev locking screw (b)(6) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm (b)(6) 320-20-00 - eq reverse torque defining screw kit additional information, including the product investigation, will be submitted within 30 days of receipt.
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Search Alerts/Recalls
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