Please note corrections to sections b2 and h6 (method, results, and conclusion codes).The reported event could be confirmed based on the x-rays inspected.The device was not returned for inspection.However, post-operative x-rays were received.The reported event could be confirmed as the humeral fracture is clearly visible.The x-rays received give indication of osteopenic bone, which could be a direct cause of the humeral fracture.Although medical error and forced fracture during the implantation could not be excluded, this could not be confirmed either since it was not possible to determine exactly when during the procedure the bone was fractured.The images received were reviewed by a medical expert, who stated: "the x-rays show a reunion reverse total shoulder arthroplasty which is positioned well.The x-rays may give the impression that the bone is osteopenic, however this are not medical grade images.The x-ray shows a fracture fragment that is a part of the greater tuberosity.I cannot assess when in the procedure this avulsion happened, it may have been (1) avulsed during humeral head dislocation, or (2) pre-damaged by the humeral head resection, or later in the procedure during (3) opening of the medullary canal or even (4) with the broaches.Obviously, in (1) and (2) neither instrument nor the device are involved.(3) and (4) would be most likely surgical technique related.Above all, the alleged poor bone quality related to all 4 phases described above.Please note that avulsion also may have happened while reducing the joint with the final implant in place, since there is a fair amount of humeral distalization in this case with the use of a thick tray." based on investigation, the root cause was attributed to a bone condition related issue.The osteopenia observed on the patient's bone could be identified as a cause of the fracture.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
|