EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Catalog Number 02-012-44-3511 |
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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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) 2014 and then was revised on (b)(6) 2023.Patient required revision surgery for issues including but not limited to pain, swelling, instability, bony defects, 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: 07 0140 14 004; item number: a10007 - full description: gps knee implant kit.Serial number: 3001497; item number: 204-32-01 - full description: fluted stem extension 11l x 12 mm.Serial number: 3629269; item number: 200-02-35 - full description: three peg patella 35mm.Serial number: 3641146; item number: 02-010-01-0335 - full description: logic femoral ps cem right sz 3.5.Serial number: 3703858; item number: 204-70-00 - full description: tibial stem ext.Screw.Serial number: 3723093; item number: 02-012-45-3535 - full description: lgc tibial fit tray cem sz 3.5f / 3.5t.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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