SMITH & NEPHEW, INC. UNKNOWN LEGION TOTAL KNEE REV FEM COMP; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNKNOWN |
Device Problem
Osseointegration Problem (3003)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 08/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).Guntin, j., bartosiak, k.A., della valle, c.J., patel, a., gerlinger, t.L., & nam, d.(2022).Radiographic and clinical analysis of a porous-coated metaphyseal cone for revision total knee arthroplasty.The knee, 37, 162-170.Doi.Org/10.1016/j.Knee.2022.04.003.
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Event Description
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It was reported that on literature review "radiographic and clinical analysis of a porous-coated metaphyseal cone for revision total knee arthroplasty", one (1) patient suffered from femoral component loosening after having a tka index revision surgery performed using legion metaphyseal cone system.This patient underwent an unspecified additional surgical intervention.The outcome of the patient is unknown.No further information is available.
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Manufacturer Narrative
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H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a patient suffered from femoral component loosening after having an index revision tka surgery (without utilization of the femoral cone) and underwent an unspecified additional surgical intervention.The outcome of the patient is unknown.It was communicated that no further information is available.Without the requested clinical documentation, no clinical factors could be definitively concluded to have contributed to the reported events.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The patient impact beyond that which was reported could not be determined.No further medical assessment can be rendered at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, size selected, loss of ingrowth, osteolysis and/or traumatic injury.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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