Tornier shoulder outcomes study - shout (subject 108-00045).Loosening of the glenoid component because of a fall down of the patient, generating a glenoid fracture.Date of explant: (b)(6) 2019.Resolved without sequelae: (b)(6) 2019.Update: according to the attached reports and an hcp review, one of the 32mm screws was broken.It is unknown which one.
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The reported event could be confirmed.Devices were not returned for investigation, but evidences were provided, based on x-rays and surgery reports which match the alleged failure.The provided pre-op x-rays show radiolucency around the peripheral screws (glenoid loosening), breakage of a peripheral screw and a baseplate bone graft out of the glenoid bone (glenoid fracture).Since surgery reports and images were provided, the opinion of a medical expert was sought and stated as following: "this patient was revised in 2015 (revision with conversion from anatomic to reversed and iliac crest bone graft of the glenoid).The x-rays show a failure of the iliac crest graft (radiolucency) and part of the graft being displaced with the glenoid baseplate" (glenoid fracture)."no doubt that a screw broke (one of the 32 mm screws)"."most likely partial resorption of the graft (radiolucency) leading to partial loosening of the baseplate, followed by a traumatic fracture of the graft displacing the baseplate together with a part of the bone graft".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.In this case, the patient conditions may have contributed to this event.It is very unlikely that the devices could have caused the reported event.More detailed information about the complaint event (as patient conditions, post-operative images before the fall) as well as the affected devices must be available in order to determine clearly the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
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Tornier shoulder outcomes study - shout (subject (b)(6) ).Loosening of the glenoid component because of a fall down of the patient, generating a glenoid fracture.Date of explant: (b)(6) 2019.Resolved without sequelae: (b)(6) 2019.Update: according to the attached reports and an hcp review, one of the 32mm screws was broken.It is unknown which one.
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