Catalog Number 10208103 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Osteolysis (2377)
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Event Type
Injury
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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2 of 2 reports.Other mfg report number: 1651501-2020-00022.Case from a study: a right cadence talat dome (size 3) was implanted 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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Udi: (b)(4).The cadence talar dome was not returned for evaluation (still implanted); therefore, an evaluation of the device could not be performed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.Potential causes for osteolysis with the talar implant include inadequate design and incorrect or inadequate surgical technique.
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Event Description
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N/a.
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Event Description
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N/a.
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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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Event Description
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N/a.
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Search Alerts/Recalls
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