STRYKER GMBH TALAR COMP,SINGLE COATED US VERS MEDIUM, RIGHT; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
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Catalog Number 400256 |
Device Problem
Fracture (1260)
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Patient Problems
Failure of Implant (1924); Pain (1994); Implant Pain (4561)
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Event Date 06/18/2021 |
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.Device disposition is unknown.
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Event Description
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A patient reported via medwatch mw5102110 that they had a star ankle replacement in 2013.Pain had steadily increased over the last six months.The doctor had to perform a polyethylene replacement (b)(6) 2021.The original insert was potentially broken.
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Event Description
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A patient reported via medwatch mw5102110 that they had a star ankle replacement in 2013.Pain had steadily increased over the last six months.The doctor had to perform a polyethylene replacement (b)(6), 2021.The original insert was potentially broken.
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Manufacturer Narrative
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H6 clinical code corrected.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 was not possible because the (correct) lot number was not communicated.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
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Search Alerts/Recalls
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