EXACTECH, INC. NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Catalog Number 130-32-51 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Failure of Implant (1924)
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Event Date 01/17/2024 |
Event Type
Injury
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Event Description
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As part of the manufacturer's recall campaign, the patient presented herself for a check on the left in 2020 implanted hip prosthesis.The x-ray control showed a clear decentration of the prosthetic head, unusually large osteolysis in the trochanter area, as well as smaller lysis in the acetabulum.Signs of inlay wear.This was possible when the inlay was changed to a vitd-hardened one on (b)(6) 2024 specially approved inlay (novation xle neutral liner, group 1, 32mm i.D., ref (b)(4), sn (b)(6)) verified.As part of the replacement operation, in addition to the inlay replacement, the firmness was determined, cup integrity as well as the curettage and sealing of the cysts in the cup bearing and shaft area using allogeneic cancellous bone and changing the prosthetic head.
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Manufacturer Narrative
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H3: pending investigation.D10: (b)(6) 180-01-48 - crown cup,cluster-hole.H7: z-2117-2021.
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Manufacturer Narrative
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Section h10: (h3) a number of variables including use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) could have all contributed to the increased trend in wear/osteolysis related complaints.The revision reported as likely the result of a combination of both patient-related conditions and the risk factors specified in an hhe.However, the extent and root cause of the reported polyethylene wear cannot be confirmed as the devices were not available for evaluation and radiographs/ photographs and operative notes were not provided.
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