Catalog Number UNK_WTB |
Device Problem
Osseointegration Problem (3003)
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Patient Problems
Osteolysis (2377); Inadequate Osseointegration (2646)
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Event Date 07/24/2023 |
Event Type
Injury
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Event Description
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The tornier shoulder outcomes study's patient experienced a revision surgery due to issues with loosening/lysis.During the procedure, a glenoid sphere was removed and replaced with a reversed-lateralized glenosphere that was 3mm larger (39mm).An additional update revealed that the tornier hrs ars741701 was also removed during the surgery.
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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.H3 other text : device disposition is unknown.
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Event Description
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The tornier shoulder outcomes study's patient experienced a revision surgery due to issues with loosening/lysis.During the procedure, a glenoid sphere was removed and replaced with a reversed-lateralized glenosphere that was 3mm larger (39mm).An additional update revealed that the tornier hrs ars741701 was also removed during the surgery.
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Manufacturer Narrative
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The reported event was not confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.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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