EXACTECH, INC. NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Catalog Number 130-36-54 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Failure of Implant (1924)
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Event Date 01/15/2024 |
Event Type
Injury
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Manufacturer Narrative
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D10: concomitant devices: (b)(6) 148-36-93 - 12/14 zirconia head 36mm rep by 170-36-93; (b)(6) 120-65-25 - bone screw 6.5mm dia x 25mm long; (b)(6) 164-01-13 - element-stem, collarless w/ha, std offset, sz 13; (b)(6) 186-01-62 - integrip cc, cluster 62mm, g4.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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It was reported via legal documentation that a patient had a right total hip replacement procedure on (b)(6) 2013 and then was revised on (b)(6) 2024.Patient required revision surgery for issues including but not limited to joint pain, limited range of motion, loss of mobility, revision surgery, and other injuries presently undiagnosed which will require on going medical care.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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