The complaint number corresponding to this medwatch is (b)(4).It is unknown if the device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Concomitant medical products: (b)(4) avenirâ® mãiller, stem, (b)(4); (b)(4) trabecular metal acetabular revision system, buttress augment (b)(4); (b)(4) trabecular metal acetabular revision system, column buttress, (b)(4); (b)(4) trabecular metal acetabular revision system, column buttress, (b)(4); (b)(4) shell with multi holes porous (b)(4); (b)(4) femoral head product (b)(4); (b)(4) constrained liner with ring (b)(4); (b)(4) bone screw (b)(4); (b)(4) bone screw (b)(4); (b)(4) bone screw (b)(4); (b)(4) bone screw (b)(4); (b)(4) screw (b)(4); (b)(4) bone screw (b)(4); (b)(4) bone screw (b)(4) (b)(4) bone screw (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-05117, 0002648920-2017-00470, 0001822565-2017-05118, 00002648920-2017-00471, 0002648920-2017-00472, 0002648920-2017-00473, 0002648920-2017-00474, 0002648920-2017-00475, 0002648920-2017-00476, and 0002648920-2017-00478.
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It was reported by patient's legal counsel that the patient died approximately two years post implantation due to respiratory failure related to chondrosarcoma.The proximate cause of her death was infection and necrosis, treated with amputation, from negligence during and after surgery.
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