EXACTECH, INC. CR TIBIAL INSERT SZ 2, 11MM, SLOPE +; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Catalog Number 200-62-11 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Failure of Implant (1924)
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Event Date 04/08/2024 |
Event Type
Injury
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Manufacturer Narrative
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D10: concomitant devices: serial number item number and full description (b)(6) h3: the revision reported was likely the result of prosthesis wear of the tibial insert.The cause of prosthesis wear is generally a combination of risk factors including use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.
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Event Description
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It was reported via legal documentation that a patient had a left total knee replacement procedure on (b)(6) 2011 and then was revised on (b)(6)2024.Patient required revision surgery for issues including but not limited to tissue and bone loss.The mostly likely cause for the revision reported due to prosthesis wear is a combination of risk factors including use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.
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Search Alerts/Recalls
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