EXACTECH, INC. OPTETRAK LOGIC TIBIAL INSERT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Catalog Number 02-012-35-2011 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Failure of Implant (1924)
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Event Date 09/17/2017 |
Event Type
Injury
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Event Description
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As reported by the legal department, approximately 8 years post op the initial tka, this female patient was revised due to aseptic loosening and osteolysis.Surgeon noted "several areas of osteolysis." upon information and belief, the loose components and osteolysis in plaintiff¿s left knee was due to premature polyethylene wear of the tibial insert.No additional information.
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Manufacturer Narrative
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These devices are used for treatment not diagnosis.No additional information.
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Manufacturer Narrative
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H3: the reported loosening/osteolysis may have been the result of an insufficient bond between the implants and the bones.The cause of the prosthesis wear cannot be determined because the revised component was not returned for evaluation and radiographs, photographs, or operative notes were not provided.
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Search Alerts/Recalls
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