EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Catalog Number 9999 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/20/2022 |
Event Type
Injury
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Manufacturer Narrative
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D10: no information available.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, a patient had a left total knee replacement procedure on (b)(6) 2017 and then was revised on (b)(6) 2022.Patient required revision surgery for issues including but not limited to polyethylene prosthesis wear, pain, and device failure.The most likely cause for the revision reported due to prothesis 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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