Catalog Number 10207114 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Osteolysis (2377)
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Event Date 11/23/2020 |
Event Type
Injury
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Manufacturer Narrative
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Udi: (b)(4).Dhr: there were no indications of problems that could have caused or contributed to the complaint.Failure could not be confirmed, the cadence tibial implant remains implanted.If the part is later returned to integra this investigation may be reopened and updated.As the part has not yet been returned, a definitive root cause cannot be determined.According to risk assessment documentation for the cadence total ankle system, potential causes for osteolysis with the tibial tray include inadequate design and incorrect or inadequate surgical technique.
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Event Description
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1 of 2 reports.Other mfg report number: 1651501-2020-00023.Case from a study: a right cadence tibial implant (size 4x) was placed on (b)(6) 2019 and on a follow up visit on (b)(6) 2020 the surgeon noted on the x-rays: "osteolysis on both tibia and talus (bone cyst around the posterior side of the tibial implant / osteolysis under the talus implant".No action or treatment plan for the moment.Surgeon advised patient to come back in 3 months for follow up.
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Manufacturer Narrative
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Additional information received on june 4, 2021: revision surgery was scheduled on (b)(6) 2021 with talus and poly exchange and potentially a tibia exchange.Additional information received on june 11, 2021: revision surgery cancelled, the patient had functional improvement since 6 weeks before the appointment on (b)(6) 2021 (unlimited walking distance, golf etc.).
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Manufacturer Narrative
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Additional information received: the site indicated that the planned revision surgery was cancelled as the patient was pain free and had adequate mobility.
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Search Alerts/Recalls
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