(b)(4).Concomitant medical products: 010000666, 6430947, g7, pps, ltd, acet, shell, 58g.Unknown, head.Unknown, stem.Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 04587.
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It was reported that during hip surgery, the e1 liner would not seat into the g7 cup.After examination of the liner, it appeared the liner was destructed on the outside.After some difficulty, the surgery was completed with a second device while using a more powerful ballimpactor.The surgery was delayed approximately 60 minutes due to the malfunction.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
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