(b)(4).Concomitant medical products: ref (b)(4), lot 64904799, shell; ref (b)(4), lot j7214202, self tapping bone screw; ref (b)(4), lot 65335217, self tapping bone screw; ref (b)(4), lot 64875044, liner; ref (b)(4), lot 3093921, ceramic head; ref (b)(4), lot 3100260, taper sleeve.(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: orif femur fracture, shaft ¿ displaced, unstable.Femoral stem easily removed.Multiple subcutaneous hematomas evacuated upon entry of recent incision; not an unexpected finding with bone fractures and recent surgery.Cable was placed distal to fracture area to protect it from propagation.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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.
|