TORNIER INC TORNIER PERFORM REVERSED ECCENTRIC GLENOSPHERE +3MM DIA 39MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION
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Catalog Number DWJ033 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problem
Osteopenia/ Osteoporosis (2651)
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Event Date 01/23/2024 |
Event Type
Injury
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Event Description
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Bony resorption along the greater tuberosity and an enlarging effusion around the proximal humerus were observed.A revision surgery was conducted, removing components such as the tray, stem, glenosphere, and insert.The relatedness to the study device was definite, while its relation to the surgical procedure was considered possible.
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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 unknown.
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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.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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Bony resorption along the greater tuberosity and an enlarging effusion around the proximal humerus were observed.A revision surgery was conducted, removing components such as the tray, stem, glenosphere, and insert.The relatedness to the study device was definite, while its relation to the surgical procedure was considered possible.
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Search Alerts/Recalls
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