TORNIER S.A.S. UNKNOWN 3.5MM HIGH OFFSET ASCEND FLEX TRAY; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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Catalog Number UNK_WTM |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Unstable (1667)
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Patient Problem
Joint Laxity (4526)
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Event Date 03/01/2024 |
Event Type
Injury
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Event Description
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As reported: "revision was of a stryker reverse shoulder for instability.The 36mm glenosphere, 36 +6mm ascend flex humeral liner and 3.5mm high offset ascend flex tray were replaced with larger sizes to ensure stability.The event occurred on (b)(6) 2024.It is unknown when the patient first started experiencing the instability.".
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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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 the available pictures are not sufficient to confirm the alleged failure.The device inspection revealed the following: the visual inspection of the available pictures reveals no signs of damage and the provided photos didn't provide much information to confirm the event.The device history record could not be reviewed because the affected device was not returned, and the catalog number and lot number were not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were 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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Event Description
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As reported: "revision was of a stryker reverse shoulder for instability.The 36mm glenosphere, 36 +6mm ascend flex humeral liner and 3.5mm high offset ascend flex tray were replaced with larger sizes to ensure stability.The event occurred on march 1st, 2024.It is unknown when the patient first started experiencing the instability.".
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