Pending evaluation concomitant device(s): equinoxe reverse adapter plate tray +5 - 320-10-05, 6230354, equinoxe reverse 38mm glenosphere - 320-01-38, 6747870, equinoxe reverse 38mm humeral liner +2.5 - 320-38-03, s130656, eq rev locking screw - 320-15-05, 6945504, eq reverse torque defining screw kit - 320-20-00, 6926688, equinoxe, humeral primary, press fit 9mm - 300-01-09, 5824106, eq rev compress screw lck cap kit, 4.5 x 30mm - 320-20-30, s270960, eq rev compress screw lck cap kit, 4.5 x 30mm - 320-20-30, s210714, eq rev compress screw lck cap kit, 4.5 x 34mm - 320-20-34, s213651, eq rev compress screw lck cap kit, 4.5 x 34mm - 320-20-34, s222422, eq rev compress screw lck cap kit, 4.5 x 42mm - 320-20-42, s117060, eq rev compress screw lck cap kit, 4.5 x 42mm - 320-20-42, 6287728.
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(h3) the revision reported was likely the result of insufficient fixation between the implants and the bones and patient-related conditions, including multiple procedures/revisions on the involved shoulder, which led to aseptic (non-infected) humeral and glenoid loosening and subsequent compression screw fracture.However, this cannot be confirmed as the devices were not available for evaluation.Section h11: the following sections have corrected information: (h6) medical device problem code: 4002, loosening of implant not related to bone-ingrowth.
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