Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, "material sensitivity reactions." number 6 states, "loosening, migration, and/or fracture of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, and/or excessive activity." number 13 states, "wear and/or deformation of articulating surfaces." this report is number 1 of 2 mdrs filed for the same patient (reference (b)(4)).
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This follow-up report is being submitted to relay additional information.Concomitant medical product - xs discovery elbow humeral condyle kit 3.5 x 84 mm lt flange, catalog#: 114991, lot#: 803430.Complaint sample was evaluated and the reported event was confirmed.There is no bony ingrowth on the stem of the humeral component.There are portions of the stem where it appears the coating is worn away.There are significant scratches and abrasions on the humeral component just proximal to the stem.The male and female condyles that were returned were observed to have circular wear marks around the entire circumference.The ulnar component and condyle lock screws were not returned and therefore, could not be evaluated.Dimensional analysis was not performed on the devices due to the damage which would cause inaccuracies in the data.X-rays were received and reviewed.The results identified: "angulation with ventral migration proximal humeral stem component.Lack of placement of a bone graft beneath the anterior flange of the humeral component may have increased force on the distal portion of the humeral component, resulting in migration/angulation of the humeral component." device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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