STRYKER GMBH TALAR COMP,SINGLE COATED US VERSION SMALL, RIGHT; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
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Model Number 400-254 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
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Event Description
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It was reported a 7mm poly for the ankle was revised and a 400-141 was implanted.
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Event Description
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It was reported a 7mm poly for the ankle was revised and a 400-141 was implanted.
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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 no other evidences were provided.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.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the complaint report will be updated.
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