EXACTECH, INC. NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Model Number NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS |
Device Problem
Naturally Worn (2988)
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Patient Problem
Failure of Implant (1924)
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Event Date 01/12/2024 |
Event Type
Injury
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Manufacturer Narrative
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Section d10: concomitant products: crown cup,cluster-hole gr.56 (cat# 180-01-56 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
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Event Description
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As reported by the germany competent authorities and as part of the manufacturer's recall campaign, the patient presented himself for a check-up of the device implanted in 2016 hip prosthesis.The x-ray control showed a clear decentering of the prosthetic head unusually large osteolysis in the acetabulum as a sign of inlay wear.This could happen to one.Inlay change on (b)(6) 2024 to a vitd-hardened, specially approved inlay (novation xle, neutral liner, group 3, 36 mm i.D., ref 140-36-53, sn (b)(6)).As part of the replacement operation, after the inlay exchange, the determination of the solid cup integrity as well as the curettage and sealing of the cysts.Socket bearing using allogeneic cancellous bone and changing the prosthetic head.
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Search Alerts/Recalls
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