Correction h6 clinical.The reported event (post-operative glenoid loosening with screw breakage) could be confirmed.The devices were not returned but evidences were provided based on the reported data in the clinical study.Since data were provided, the opinion of a medical expert was sought and stated as following: "the surgical report doesn¿t mention anything out of the ordinary, except for the degeneration pattern of the glenoid.The surgeon addressed the deformity with a reversed tsa, using a bone graft around the central post of the glenoid baseplate.The ct-scan of (b)(6) 2019, that is approximately 6 months after the index surgery (b)(6) 2019), the baseplate has migrated away from the glenoid, leaving behind the distal part of one broken baseplate screw.The bone graft was attached to the baseplate, thus the construct failed at the bone graft-glenoid interface.(.) the issue is primary a patient related factor (¿namely the bone graft did not heal properly/timely on the glenoid side, leading to baseplate migration and secondary screw breakage¿, ¿presence of poor bone quality¿), but on second thought, underestimation of the severity of the large subchondral cyst can be seen as a user-related issue (¿in retrospect the subchondral cyst was so large that primary fixation was already inadequate¿, ¿osteointegration was not sufficient¿)".Based on investigation, the root cause was attributed to a user related issue.The failure was caused by an underestimation of the hcp of the patient's initial conditions.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
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