TORNIER INC TORNIER PERFORM REVERSED FULL WEDGE BP 15 DG DIA 25MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION
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Catalog Number DWJ505 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Osteolysis (2377); No Clinical Signs, Symptoms or Conditions (4582)
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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.
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Manufacturer Narrative
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This device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
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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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