(b)(4).Concomitant products: 15-103692 680910 universal alternative bearing shell 62mm 2-hole with screw 41 mm i.D.Taper/ porous coated; 15-105004 021690 m2a taper liner 32mm i.D.Size 41mm o.D.Taper; 103207 675870 modual taperloc femoral porous coated 13.5 x 147mm type i taper.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-03607, 0001825034-2017-03608, 0001825034-2017-03610.
|