EXACTECH, INC. KNEE COMPONENTS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
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Device Problem
Insufficient Information (3190)
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Patient Problem
Failure of Implant (1924)
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Event Date 02/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Pending investigation.
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Event Description
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As reported by a legal notification, the patient had an initial tka in 2011.On or around (b)(6) 2020, the patient was revised.Reason not reported.No other patient information/medical history reported.
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Manufacturer Narrative
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H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
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Search Alerts/Recalls
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