EXACTECH, INC. CC TIBIAL INSERT SZ 3, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
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Model Number CC TIBIAL INSERT SZ 3, 15MM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bacterial Infection (1735)
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Event Date 10/13/2022 |
Event Type
Injury
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Manufacturer Narrative
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As reported, approximately eleven years post initial left side tka of a 74 y/o male patient, the surgeon performed a wash out of the infected knee and replaced the poly as part of the washout.The patient was revised to exactech devices.There was no breakage of device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.The device is not available for evaluation due to device was disposed by the hospital.No additional information.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely patient-related conditions.These devices are used for treatment not diagnosis.
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Event Description
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As reported, approximately eleven years post initial left side tka of a 74 y/o male patient, the surgeon performed a wash out of the infected knee and replaced the poly as part of the washout.The patient was revised to exactech devices.There was no breakage of device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.The device is not available for evaluation due to device was disposed by the hospital.No additional information.
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