Catalog Number UNK_WTB |
Device Problem
Migration (4003)
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Patient Problems
Fall (1848); Non-union Bone Fracture (2369); Limb Fracture (4518); Multiple Fractures (4519)
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Event Date 06/08/2023 |
Event Type
Injury
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Manufacturer Narrative
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Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device not returned.
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Event Description
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It was reported that the patient underwent a revision surgery due to the baseplate coming away from the glenoid and a further fractured humerus following a fall.The patient had non-union, acromium fracture, scapula spine fracture as a result of the fall and prior to the revision.
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Manufacturer Narrative
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The reported event could be confirmed, since based on the available x-rays and formal medical opinion.The opinion of the medical expert was requested and stated as following: ¿the x-ray confirms the migration of the glenoid component construct (baseplate and glenosphere) but it cannot be assessed if it was because of patient¿s fall.¿ 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.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.Based on the available x-ray and formal medical opinion the root cause cannot be determined.If the device is returned or if any additional information is provided, the investigation will be reassessed.¿.
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Event Description
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It was reported that the patient underwent a revision surgery due to the baseplate coming away from the glenoid and a further fractured humerus following a fall.The patient had non-union, acromium fracture, scapula spine fracture as a result of the fall and prior to the revision.
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Search Alerts/Recalls
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