(b)(4).Concomitant products: unknown trilogy modular trabecular metal shell, unknown femoral head, unknown versys fully porous-coated femoral stem; therapy date unknown.Abdel, m.P., chalmers, b.P., trousdale, r.T., hanssen, a.D., and pagnano, m.W.(2017).Randomized clinical trial of 2-incision vs mini-posterior total hip arthroplasty: differences persist at 10 years.The journal of arthroplasty.Doi:10.1016/j.Arth.2017.04.005.No devices or photos of the devices were received; therefore, the condition of the components is unknown.Additionally, visual and dimensional evaluations could not be performed.The product number and the lot number were not provided; therefore, the manufacturing date, the device history records and the field age of the device could not be determined.There is insufficient information to perform a complaint history search.A definitive root cause could not be determined, as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-03715, 0001822565-2017-03716, 0001822565-2017-03717.
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