Correction: h6 device code.The reported event could not be confirmed since the device was not returned for evaluation.However, the tornier shoulder outcomes study for this patient was available.This document was reviewed by the medical expert.The opinion of the medical expert state as following: "the female patient with a healthy weight and no co-morbidities that may influence the outcome, received an anatomic shoulder replacement of the right shoulder on (b)(6) 2017.The indication was primary osteoarthritis with an intact rotator cuff, mild glenohumeral degeneration and concentric wear of the native glenoid.The shoulder was replaced by the combination of a uncemented simplicity 43x16 mm humeral component in combination with a s40 perform pegged (partially) cemented glenoid component.At 1&2-year follow up the patient was very satisfied with the outcome.The file doesn¿t report on the x-ray follow-up at those times.The adverse event was reported on (b)(6) 2022 as component loosening, described as: x-rays show increased anterior and superior glenoid erosion and lucency.For this medical opinion, the images were not available for reviewing.In my opinion there a no medical or health-reasons involved in this adverse event.Other factors such as implant positioning, change of implant positioning, clues for rotator cuff degeneration and/or altered joint mechanics and third body wear explaining possible accelerated glenoid component wear, cannot be assessed at this time.For that, the x-rays must be reviewed." 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.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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