EXACTECH, INC. NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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Catalog Number 130-32-52 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Failure of Implant (1924)
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Event Date 06/30/2022 |
Event Type
Injury
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Manufacturer Narrative
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Pending evaluation.Concomitant device(s): cup.
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Event Description
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It was reported that this 73 y/o male patient's right hip was revised due to the poly wear.Patient had cup and liner removed and a smith and nephew ceramic cup and liner were implanted.Patient was last known to be in stable condition following the event.Device will not be returning, hospital threw it away.
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Manufacturer Narrative
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Section h10: (d1) brand name: nv gxl linr, ntrl, 32mm id, group 2 cups (d4) catalog number: 130-32-52, serial number: (b)(6) expiration date: 10-feb-2020, unique identifier (udi) #: (b)(4).(g5) pma/510(k)number: k070479 (h3) the revision reported was likely the result of eccentric prosthesis wear of the acetabular liner over 7 years of implantation.However, this cannot be confirmed as the devices are not available for evaluation.(h4) device manufacture date: 13-feb-2015 section h11: *the following sections have corrected information: (d10) concomitant device(s): 186-01-54, 3718125 - integrip cc, cluster 54mm, g2 (h6) component code: 734, bearings.
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