(b)(4).The device will reportedly be returned for analysis, but has not yet been received by the manufacturer; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Concomitant products: 650-1068 biolox option hip system taper adapter lot 692060; ep-200150 active articulation hip system dual mobility bearing lot 404860; unknown femoral stem; unknown acetabular cup.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-03852, 0001825034-2017-03856 and 0001825034-2017-03857.
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It was reported that the ceramic head, taper adapter and dual mobility bearing would not assemble with the existing stem during a revision procedure.Another head, taper adapter and bearing were used to complete the procedure, resulting in a 40 minute delay.There were no additional patient consequences.
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