Catalog Number DWJ014 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Osseointegration Problem (3003)
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Patient Problems
Inadequate Osseointegration (2646); Joint Laxity (4526)
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Event Date 08/18/2023 |
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.H3 other text : device disposition is unknown.
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Event Description
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There was a revision of a tornier product, specifically a perform reverse glenoid with a perform humeral stem.The baseplate and stem were not removed but were adjusted by lateralizing the glenoid sphere.A spacer and a new poly component were used on the humeral side.The revision was necessary due to inadequate tensioning in the initial procedure.An update confirmed that the revision was successful, and it involved changing a standard glenosphere for a lateralized one and building up the poly component on the humeral side.
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Manufacturer Narrative
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Please note the corrections made to the device code, clinical signs code, and health impact: 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.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 or 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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Event Description
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There was a revision of a tornier product, specifically a perform reverse glenoid with a perform humeral stem.The baseplate and stem were not removed but were adjusted by lateralizing the glenoid sphere.A spacer and a new poly component were used on the humeral side.The revision was necessary due to inadequate tensioning in the initial procedure.An update confirmed that the revision was successful, and it involved changing a standard glenosphere for a lateralized one and building up the poly component on the humeral side.
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Search Alerts/Recalls
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