EXACTECH, INC. NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Catalog Number 136-32-51 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Failure of Implant (1924)
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Event Date 02/14/2023 |
Event Type
Injury
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Manufacturer Narrative
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D10: concomitant devices: 2135060 186-01-50 - integrip cc, cluster 50mm, g1; 2538871 101-45-40 - 4.5mm drill bit 40mm; 2563052 122-65-25 - 6.5mm acetabular bone screw 25mm.H7: recall number z-1729-2022.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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As reported via legal documentation, a patient had a left total hip replacement procedure on (b)(6) 2013 and then was revised on (b)(6) 2023.The patient required revision surgery for issues including but not limited to polyethylene prosthesis wear, component loosening, 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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Search Alerts/Recalls
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