(b)(4).The initial report was submitted on 0001822565-2020-03939.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Operative notes were not provided; xrays were provided and reviewed by a health care professional.Superior dislocation of the left femoral head on both images and interval placement of the proximal cerclage wires within the left femoral diaphysis.Possible implant disassembly of the acetabular cup on image two.Left acetabular inclination angle is 46°.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 04127, 0002648920 - 2020 - 00533.
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