EXACTECH, INC. TIBIAL INSERT MB SZ 1 RT 6MM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number TIBIAL INSERT MB SZ 1 RT 6MM |
Device Problem
Fracture (1260)
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Patient Problem
Failure of Implant (1924)
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Event Date 11/16/2023 |
Event Type
Injury
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Manufacturer Narrative
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Section d10: concomitant products - taluskappe 1, re (cat# 350-02-01e / serial# (b)(6)) - tibiaplateau mobil 3, re (cat# 350-32-03 / serial# (b)(6)) additional information, including the product investigation, will be submitted within 30 days of receipt.
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Event Description
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As reported by the germany competent authorities after sprain trauma on the right foot, the polyethylene inlay of the endoprosthesis fractured (secured intraoperatively).In the august 2022 notice from the company about a lack of oxidation barrier in the packaging with the possible consequence of inlay damage when stored > 5 years.Although in germany there are no inlays with one if the implant has been implanted for a storage period of > 5 years, this notification is made as a precautionary measure.
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Search Alerts/Recalls
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