|
Model Number 320-20-34 |
Device Problem
Break (1069)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 12/15/2021 |
Event Type
Injury
|
Event Description
|
As reported, this (b)(6) male patient's left shoulder was revised due to the baseplate screws breaking.The baseplate, glenosphere, tray, and liner were revised.Patient was last known to be in stable condition following the event.Devices will not be retuning due to hospital policy.
|
|
Manufacturer Narrative
|
Pending evaluation.Concomitant device(s): 320-01-42 - equinoxe reverse 42mm glenosphere 6261376.320-10-00 - equinoxe reverse tray adapter plate tray +0 6327221.320-15-03 - rs glenoid plate l post aug, 8 deg, left 6372301.320-15-05 - eq rev locking screw 6250582.320-20-00 - eq reverse torque defining screw kit 6255022.320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm 6265939.320-42-00 - equinoxe reverse 42mm humeral liner +0 6340484.
|
|
Manufacturer Narrative
|
Section h10: (h3) the revision reported was likely the result of the glenoid baseplate not achieving long-term fixation, causing the compression screws to bear the joint load and eventually fracture.However, this cannot be confirmed as the devices were not returned for evaluation and adequate information was not provided to determine the root cause of the insufficient glenoid baseplate fixation.
|
|
Search Alerts/Recalls
|
|
|