The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition unknown.
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The manufacturer became aware of a post market clinical follow-up report received from (b)(6) medical center, united states.The title of this report is ¿a presentation of the last 20 consecutive cases using the hoffman lrf hexapod for limb salvage and deformity correction.¿ which is associated with the stryker ¿hoffmann lrf¿ system.The treatment period of patients included in this report was between 2018 and 2020.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore 9 complaints were initiated retrospectively for the post-operative complications mentioned in the report.This product inquiry addresses pain at the m-l half pin with serous drainage off and on for 2 weeks.The report states: ¿postoperatively, the patient continued to have pain at the m-l half pin without any evidence of infection although there was serous drainage off and on for 2 weeks.The patient continued to have pain but was able to bear weight on the foot.The frame was removed at 3 months and the patient underwent 4 weeks of physical therapy.Pain at the half-pin site is steadily improving and is likely secondary to a stress reaction or microfracture.The patient reports 70% improvement in discomfort which is life altering and therefore considered successful.¿.
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