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Model Number 200-73-09 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
Failure of Implant (1924)
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Event Date 08/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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Procodes: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical products: 2545998 200-02-38 - three peg patella 38mm; 2410965 204-04-33 - trapezoid tibial tray sz 3f/3t; 1524883 230-03-03 - optetrak asy,cr cemented femoral, sz 3.Pending investigation.
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Event Description
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It was reported via the legal department that on january 17, 2013, the patient underwent a right total knee replacement.On (b)(6) 2017, approximately 4 year 5 months after implant, the patient then had a revision of the exactech knee device secondary to right total knee arthroplasty failure due to polyethylene liner wear with resulting metallosis and aseptic loosening.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
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Manufacturer Narrative
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H6: investigation results - the revision reported may have been the result of polyethylene liner wear resulting in metallosis and aseptic loosening as stated in the legal documentation.The wear may have been the result of overall posterior slope of the tibial insert and/or patient related conditions, which allowed for excessive posterior contact.The metallosis may have been due to metal on metal contact between the femoral component and tibial tray as a result of the polyethylene wear.The aseptic (non-infected) loosening may have been the result of an insufficient bond between the implant and the bone.However this cannot be confirmed as the devices were not returned for evaluation, and radiographs, photographs, and operative notes were not provided.
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Search Alerts/Recalls
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