(b)(4).Udi # n/a.Medical products: item # 00830004500, tibial component size 5 right, lot # 63028696.Item # 00830005500, talar component size 5 right, lot # 62898131.Item # 00235701706, distal lateral fibular plate right 6 holes 106 mm length, lot # 63301086.Item # unknown, unknown screws, lot # unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02374, 0001822565-2019-02375, 0001822565-2019-02439, 0001822565-2019-02440.Patient not revised.
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It has been reported the patient underwent a total ankle arthroplasty.Subsequently, the patient experienced increased numbness in the plantar foot secondary to nerve compression two (2) years post initial surgery.No revision or further treatment performed at this time; however, it was noted that the event was resolved.No additional patient consequences were reported.
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