The manufacturer became aware of a pmcf final study report that was conducted by northshore university healthsystem, us.The title of this report is ¿a retrospective data collection of the treatment of shoulder joint replacement with the aequalis ascend flex shoulder system¿, which is associated with the stryker ¿aequalis ascend flex shoulder ¿system.This report includes an analysis of the clinical data that was collected on 179 patients, the cases in this study ranged from 2013-to 2020.During the review of the literature, it was not possible to establish a specific device detail and patient information, and at this time no additional device information is available.It was reported that one patient experienced poor results in the total shoulder with persistent pain and poor range of motion.Following a ct scan that demonstrated, revision surgery was scheduled.The patient expired from other causes prior to that surgery.The report states: ¿(b)(6) with a reverse total shoulder for rotator cuff arthropathy was re-admitted eight days post-operatively for a pulmonary embolus.The patient recovered from this but was very limited by multiple other significant medical conditions.She had a poor result of the total shoulder with persistent pain and poor range of motion.Following a ct scan that demonstrated, revision surgery was scheduled.The patient expired from other causes prior to that surgery.¿.
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This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged pulmonary embolus, poor range of motion, and persistent pain could not be confirmed, since the device was not returned for evaluation and no other additional information was received from the author.More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
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