Smr reverse revision surgery planned but not yet performed due to dislocation and pain.According to the complaint source, patient has a very complicated clinical history: on (b)(6) 2022 patient presented with dislocation and open reduction was planned; on (b)(6) 2022 the open reduction with fracture repair was completed successfully.This event was registered as lima corporate complaint (b)(4) and reported to fda as mfr 3008021110-2022-00111.On (b)(6) 2022 patient presented with pain after post operative exercises.X-rays showed dislocation and signs of implant loosening; revision surgery performed on (b)(6) 2022.During the revision surgeon, surgeon commented he opted for a standard glenosphere to be implanted but the ideal component to be implanted would have been a compassionate use device component (hp reverse glenosphere).This event is registered as lima corporate complaint (b)(4) and was reported to fda as mfr 3008021110-2022-00110.Smr reverse revision surgery planned but not yet performed due to dislocation and pain (object of this report).Event happened in us.
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