EXACTECH, INC. NV GXL LNR, LIPPED 32MM ID GROUP 2 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Catalog Number 132-32-52 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Failure of Implant (1924)
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Event Date 07/08/2022 |
Event Type
Injury
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Manufacturer Narrative
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D10: concomitant devices: 1548789, 122-65-25 - 6.5mm acetabular bone screw 25mm.1572576, 180-01-52 - nv crown cup clstr hole 52mm group 2.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) 2009 and then was revised on (b)(6) 2022.The patient required revision surgery for issues including but not limited to polyethylene prosthesis wear, component loosening, device failure, revision surgery, joint pain, joint swelling, effusion, inflammation, knee popping/clunking, knee giving way, difficulty walking and antalgic gait.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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