EXACTECH, INC. NV GXL LNR, NEUTRAL, 32MM ID, GROUP 4 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Catalog Number 130-32-54 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Failure of Implant (1924)
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Event Date 11/24/2023 |
Event Type
Injury
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Event Description
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As part of the manufacturer's recall campaign, the patient presented himself for a check-up of the device implanted in 2017 hip prosthesis.The x-ray control showed a clear decentering of the prosthetic head, osteolysis in the acetabulum as a sign of inlay wear.This was possible when the inlay was changed on (b)(6) 2023 on a vitd-hardened, specially approved inlay (novation xle neutral liner, group 4, 36mm i.D., ref 140-36-54, sn (b)(6)).As part of the replacement operation, the inlay was replaced.Determination of the solid cup integrity as well as the curettage and sealing of the cysts in the cup bed using allogenic spongiosa and changing the prosthetic head.
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Manufacturer Narrative
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H3: pending investigation.H7: z-2117-2021.
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Manufacturer Narrative
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H3: based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified in the hhe: implanted with a component having a shelf age of greater than 2 years.The most likely cause for the revision reported due to early prosthesis wear and osteolysis is a combination of the risk factors specified in the hhe.However, this cannot be confirmed from the reported information.
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Search Alerts/Recalls
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