EXACTECH, INC. NV GXL LINER LIPPED 36MM ID GROUP 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Catalog Number 132-36-52 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Failure of Implant (1924)
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Event Date 02/06/2024 |
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 total hip replacement procedure on (b)(6) 2018 and then was revised on (b)(6) 2024.Patient required revision surgery for polyethylene prosthesis wear.The mostly 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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Manufacturer Narrative
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D10: concomitant products: 4767729 164-01-14 - element-stem, collarless w/ha, std offset, sz 14.5456749 186-01-52 - integrip cc, cluster 52mm, g2.5471927 170-36-00 - biolox delta femoral head 36mm od, +0mm.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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