Model Number DWB993 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
Bone Shedding Debris (4557)
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Event Date 05/05/2021 |
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.Retained at medical facility.
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Event Description
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Surgeon removed reversed ii stem and insert due to notching of scapula.He also removed the glenosphere.Replacement glenosphere was our 10 degree tilt and the stem was replaced by another company model.Issue noted initially when reviewing x rays of patients shoulder.
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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 no other evidence were provided.The device inspection was not possible as the product was not returned for investigation.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.More detailed information about the complaint event as well as the affected device must be available 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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Event Description
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Surgeon removed reversed ii stem and insert due to notching of scapula.He also removed the glenosphere.Replacement glenosphere was our 10 degree tilt and the stem was replaced by another company model.Issue noted initially when reviewing x rays of patients shoulder.
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Search Alerts/Recalls
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