Catalog Number DWB993 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/13/2024 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
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Event Description
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It was reported that the patient underwent a revision of reverse ii glenoid and poly liner.The glenoid component had broken away from the glenoid.The glenosphere and baseplate had dissociated and there was poly wear.The implants were removed and replaced.A screw was used to remove the poly liner.
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Event Description
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It was reported that the patient underwent a revision of reverse ii glenoid and poly liner.The glenoid component had broken away from the glenoid.The glenosphere and baseplate had dissociated and there was poly wear.The implants were removed and replaced.A screw was used to remove the poly liner.
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Manufacturer Narrative
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The reported event could not be confirmed, since the device was not returned for evaluation and provided image is not sufficient to confirm the event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing & design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.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.If device is returned or any further information is provided, the investigation report will be reassessed.
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Search Alerts/Recalls
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