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 10/02/2023 |
Event Type
Injury
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Manufacturer Narrative
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D10: concomitant devices: n/a 32135-38h - flex drill m3.2x38 hd lenkbar.5632905 186-01-54 - integrip cc, cluster 54mm, g2.5751845 186-01-54 - integrip cc, cluster 54mm, g2.6013023 170-32-03 - biolox delta femoral head 32mm od, +3.5mm.6165213 188-00-08 - wedge plasma s/o sz 8.6192150 170-32-00 - biolox delta femoral head 32mm od, +0mm.6247573 188-01-07 - wedge plasma x/o sz 7.S031512 180-65-25 - alteon 6.5mm screw, 25mm.S035582 180-65-25 - alteon 6.5mm 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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It was reported via legal documentation that a patient had a left total hip replacement procedure on (b)(6) 2020 and then was revised approximately 3 years 8 months later on (b)(6) 2023.Patient was recommended elective revision surgery due to implant recall for prosthesis wear.During the removal of the original implant, it was found that the acetabular liner had grossly mild wear.The patient was transferred to recovery in stable condition; no complications and procedure was tolerated well.The patient was revised to exactech devices.There is no other information provided/available.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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