SMITH & NEPHEW, INC. JOURNEY BCS / JOURNEY II BCS KNEE FEM COMP; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
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Catalog Number UNKNOWN |
Device Problems
Corroded (1131); Device Dislodged or Dislocated (2923)
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Patient Problems
Failure of Implant (1924); Infiltration into Tissue (1931); Joint Laxity (4526)
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Event Date 03/03/2022 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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It was reported that, after total knee arthroplasty was performed in 2010, the patient experienced wear on the poly and a potential cell attachment to the femoral component.It was determined that there was corrosion and external rotation of the femoral component, as well as severe wear and oxidation on the poly from engagement to the femoral component, that lead to joint instability.The poly was also confirmed to present localized delamination on medial condyle, anteriorly, and cracks anteriorly.In addition, the tibial baseplate was observed to be worn.Analysis of metal ion levels of periprosthetic tissue demonstrated high levels of ti (110 ppm), al (14 ppm), and v (5.3 ppm), which are trace of elements from the tibia baseplate (tialv alloy), confirming the generation of debris that resulted in tissue staining.This adverse event was treated with a revision surgery on (b)(6) 2022.Patient's current health status is unknown.
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Manufacturer Narrative
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H10: the device was not returned for evaluation, but the pictures were reviewed, and they confirm that the device shows organic corrosion on its surface.Wear and joint instability in a tka with external rotation of the femoral component was confirmed.The clinical/medical investigation concluded that, per the citra implant retrieval report, the revision was due to ¿wear and joint instability in a tka with external rotation of the femoral component, gross pe wear including of the ps post, and severe backside wear¿, also noting ¿tissue staining, ps post and condyle delamination, likely 3rd body wear and unexpected finding of gross backside wear of both the pe and the tibial component¿.Although likely multi-factorial, based on the limited information provided, further root cause analysis cannot be performed.The patient impact beyond that which was reported, including the revision, cannot be determined.No further medical 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.Potential causes could include but are not limited to friction, joint tightness, abnormal loadings on the implant or lifetime of device.The contribution of the device to the reported event could be corroborated since a revision surgery was required to exchange the damaged implant.Based on this investigation, the need for corrective action is not indicated.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.Internal complaint reference number: (b)(4).
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