EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Catalog Number 02-012-35-3009 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Failure of Implant (1924)
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Event Date 02/06/2019 |
Event Type
Injury
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Event Description
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It was reported via legal documentation that a patient had a right total knee replacement procedure on (b)(6) 2012 and then was revised on (b)(6) 2019.Patient required revision surgery for issues including but not limited to pain, swelling, instability, and device failure.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: concomitant devices: serial number item number and full description: (b)(6) 02-010-01-0330 - logic femoral ps cem right sz 3.(b)(6) 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.(b)(6) 200-02-35 - three peg patella 35mm.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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