Corrections: refer to d2a common device name.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.Based on previous similar cases, the glenoid/humeral dislocation/instability problem is often due to the following reasons: previous surgery (previous osteosynthesis, hemiarthroplasty, total anatomic reversed prosthesis), delto-pectoral approach, obesity or bone conflict inducing a lever-out effect, soft-tissue deficiency (subscapularis, deltoid), shortened humerus due to proximal bone loss or improper restoration of the humeral length, excessive glenoid medialization due to glenoid bone defect, insufficient glenoid bone stock or poor bone quality leading to a weak anchorage of the glenoid implant, intraoperative inadequate choice of the components, improper positioning of the implant components, traumatic event, reeducation procedure not respected, or inadequate patient use in post-operative (surgeon advices not respected).A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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