ENCORE MEDICAL, L.P. UNKNOWN STAR ANKLE; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
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Catalog Number UNK_SEL |
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 06/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.
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Event Description
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It was reported that a patient returned with failed star total ankle, that needs a revision for his insert.Additionally, it was reported that the procedure was extended however the length of the extension is unknown.
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Search Alerts/Recalls
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