It was reported that upon impaction of tibial tray, the posterior aspect of the tibia fractured at location of posterior fin on tibial implant, in addition the medical malleolus was fractured.The event lead to 45 minutes surgical delay.Additional information was requested and the following was received: procedure being performed was a total ankle replacement.The event led to two fractures: medial malleolus during bone removal and posterior fracture during tibial impaction.The medial malleolus was repaired with a plate and no treatment required for posterior fracture.The product will remain implanted unless a revision surgery is needed.
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Integra has completed their internal investigation on november 10, 2016.The investigation included: methods: review of device history records.Review of complaints history.Results: dhr review; no lot number was provided therefore the manufacturing record could not be determined.Complaints history; a review of the complaint records for the same product (or similar products within the product family) for the alleged hazardous situation/failure mode received, determined three complaints of fractured tibial trays have been received during the lifetime of the product as specified in the risk management plan (rmp), typically 5 years or within the stated timeframe the complaint rate was calculated based on the number of devices affected by the hazardous situation or failure mode, over the number of surgeries or units sold during the period of the review.Complaint rate = (b)(4).Conclusion: a root cause could not be determined due to the absence of the devices to evaluate.Based on the description provided, potential causes for the breakage could be factors such as stress placed upon the medial side of the ankle from the syndesmosis (connective tissues) and performing procedures with hard bone.In addition, if the tibial trays seating is misaligned, the engagement of the posterior fin could potentially fracture the posterior aspect of the tibia during impacting.In this particular case, the surgeon was not concerned and believes that it will heal and that the anterior cortex is covered and well affixed in the hard bone.
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