This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: overall fit and alignment appears normal, although there subtle varus alignment of the proximal femur related to the periprosthetic fracture.No confirmed signs of loosening, wear, or radiolucency.No confirmed contributing factors; however both the proximally placed screws are not centrally positioned within the femoral head.It is uncertain if this could be a contributing factor, but such a possibility is not excluded.Mmi noted bone fracture, however, with only one x-ray and cerclage wires already present, it remains unknown whether this was a new fracture or a malunion of the previous fracture.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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