Per (b)(4).Additional information, including post primary and pre revision x-rays, operative notes, patient details, an update on the patient following the revision and return of the explanted devices has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate device details have been provided and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time of manufactre.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.
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Per -(b)(4) final report additional information, including x-rays, operative notes, patient details, an update on the patient following the revision and return of the explanted devices was requested in order to progress with the investigation of this event.The patient medical history and an update on the patient following the revision were not available.No trauma was reported prior the revision.Blood testing results were provided which confirm the high ions levels.Operative notes and a pre-revision xray were provided.The cup seemed well-fixed, at an appropriate position.The appropriate device details have been provided and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.The explanted devices were returned to corin: the corin devices were coupled with a taper conversion sleeve (manufacturer unknown) and an off-label stem.Examination of the cormet devices did not present any obvious failure modes or abnormal device characteristics and there were no signs of gross wear on the bearing surfaces of the cormet implants.Both the cormet cup and head exhibited surface characteristics expected of a device implanted for more than 13 years.Based on the information provided, no further investigation can be conducted and the rootcause remains unkown.Thus this case is now considered closed.Should any additional information be available, the case will be reopened.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
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