Model Number NB015K |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 12/06/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Implanted date is unknown at the time of this report.Investigation is on-going.Additional information / investigation results will be provided in a supplemental report.
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Event Description
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It was reported that a patient required a revision surgery following a periprosthetic fracture that caused the femoral stem to break out of the femoral component.Limited information was provided in the initial report; additional information has been requested, however, has not been provided at the time of this report.
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Manufacturer Narrative
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The components were examined visually and microscopically with the digital microscope.The box of the femur components has fractured on the lateral side, at the interface to the femur shaft.The fracture surface exhibit no materials defects like foreign particles inclusion or blow holes.We assume that the fracture origin is at the ventral edge of the lateral side of the box.The top of the femur box as well as the corresponding distal end of the stem exhibit wear marks due to relative motion.The medial side of the box exhibits pressure marks showing leverage of the femur stem-medial side was under pressure and the lateral side was under tension.The hinge ring shows no signs of the hyperextension.The device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from this batch (leading product nb015k-batch number: 51831542).Based on the information available as well as a result of our investigation the root cause of the failure is probably patient related.According to the quality standard and dhr files a materials defect and production error can be excluded.It could be possible that due to the mentioned periprosthestic fracture of the femur the primary stability and therefore the secondary stability was insufficient.The stem-implant interface was loaded more severely than usual.It can be assumed that the increased loading situation generated on the box of the femur component, lead to the breakage.No capa is necessary.
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Search Alerts/Recalls
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