ENCORE MEDICAL, L.P. SLIDING CORE,UHMPWE,10MM; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
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Model Number 400-144F |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cyst(s) (1800); Implant Pain (4561)
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Event Date 10/21/2022 |
Event Type
Injury
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Event Description
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It was reported that there was a revision of a star sliding core total ankle implant.The patient came in reporting pain at tibial site.The surgeon noticed that there was a cyst forming at the top of the tibia and decide to remove the cyst and the 10mm poly.Due to removal the surgeon replaced the site with an 11mm poly, because there was space after they cut the cyst out.The surgeon did not report that the poly caused this and the original poly was intact.
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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.H3 other text : device discarded.
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Search Alerts/Recalls
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