It was reported that upon impaction of tibial tray, the posterior fragment of the patient's tibia fractured at location of posterior fin on tibial implant.Additional information was requested and the following was received on september 29, 2016: surgeon was not concerned with injury because this fracture will heal on its own.Device remains implanted.Revision surgery will be needed in the future only if the tibial tray does not seat properly.
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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 3 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.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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