TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE STAR ANKLE SYSTEM; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
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Model Number 400-142F |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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It was reported on 06/01/2023, by independent sales representative, via text to the regional account coordinator, asking for the price of a star ankle poly that was used during a star poly exchange case at (b)(6) specialty hospital on (b)(6) 2023.In a follow up email with the regional account coordinator stated "the original poly broke causing the revision case." he stated the original implant was a 400-142f, sliding core, uhmpwe, 8mm, and was implanted in 2021.The original facility, surgeon, and patient information are unknown.The 400-142f was discarded by the facility.
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Event Description
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The initial polyethylene component experienced structural failure, leading to the need for a revision procedure.The original implant employed was a 400-142f, sliding core, ultra-high molecular weight polyethylene (uhmpwe) material, with a diameter of 8mm, and had been surgically placed in 2021.
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Search Alerts/Recalls
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