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 03/21/2024 |
Event Type
Injury
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Event Description
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It was reported via legal documentation that a patient had a left knee replacement procedure on (b)(6) 2019 and then was revised on (b)(6) 2024.Implanted device information is not able to be determined from the information provided.Patient required revision surgery for issues including but not limited to polyethylene prosthesis wear and component loosening.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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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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Search Alerts/Recalls
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