It was reported via a voluntary medwatch report #mw5152512 , that a male patient, initial left shoulder implanted on (b)(6) 2021, who underwent a revision procedure on (b)(6) 2021, underwent a second revision procedure on (b)(6) 2024, approximately 2 years 7 months post the first revision procedure.Following the initial implant procedure, the reporter called to report problems after her husband received 2 equinoxe shoulder system replacements, each for the left shoulder.The reporter states her husband had initial shoulder replacement surgery on (b)(6) 2021, and came down with an infection almost immediately after implant, confirmed by a ct scan.All shoulder components were removed except for the shoulder ball, and the shoulder site was thoroughly washed out before a new equinoxe device was again implanted on (b)(6) 2021.She states her husband was prescribed doxycycline at that time and continues with that prescription today.The reporter states that after this replacement surgery, her husband continued to experience pain and limited range of motion in the left shoulder.She stated that on an unknown date in 2024, x-rays showed broken screws in the equinoxe shoulder system and an explant procedure was once again performed.They stated that on an unknown date in 2024, the surgical incision site developed a hematoma and required medical attention.She stated that in january 2024, she received a notification on her cell phone that the equinoxe shoulder system was ¿under a fda recall¿ and learned her husband¿s two equinoxe shoulder sytems were part of the recall.No further information.
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(h3) pending evaluation (d10) concomitant device(s): 3777348 - 320-10-15 - humeral tray +15mm 6580730 - 320-08-38 - glenosphere exp 38mm +4mm offset 6822073 - 300-01-11 - equinoxe, humeral stem primary, press fit 11mm 6943150 - 320-20-00 - eq reverse torque defining screw kit (b)6)- 320-15-05 - eq rev locking screw s244095 - 320-38-00 - 145-deg pe 38mm hum liner +0.
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