PHOTODYNAMIC BONE STABILIZATION SYSTEM

Additional Manufacturer Narrative

A MEDICAL OVERSIGHT REVIEW MEETING WAS HELD WHERE THE INFORMATION AND X-RAYS WERE REVIEWED. THE MEDICAL REVIEWER IDENTIFIED THAT THE INITIAL FIXATION LIKELY LACKED ROTATIONAL STABILITY. EVEN WITH THE USE OF 2 ILLUMINOSS IMPLANTS, THE PORTION OF THE HUMERUS PROXIMAL THE FRACTURE HAD RELATIVELY SHORT LENGTHS OF ILLUMINOSS IMPLANTS. THE MEDICAL REVIEWER STATED THAT WITH THE ABSENT ROTATIONAL STABILITY THE FRACTURE IS LESS LIKELY TO HEAL. THE DIAGNOSTIC RADIOLOGY REPORT STATED THAT THE FRACTURE WAS NOT HEALING AND A NONUNION WAS PRESENT, AND THE MEDICAL REVIEWER NOTED THAT THE NONUNION IS THE MOST LIKELY SOURCE OF PAIN THE PATIENT IS EXPERIENCING. IT IS ALSO POSSIBLE THAT THE METASTATIC LESIONS ARE CAUSING THE PATIENT PAIN, BUT LIKELY THAT THE NONUNION AT THE FRACTURE SITE IS THE PRIMARY SOURCE. THE MEDICAL REVIEWER OBSERVED THAT A SUPPLEMENTAL PLATE, EITHER AT THE INDEX PROCEDURE OR LATER ON COULD HAVE BEEN UTILIZED TO GIVE BETTER ROTATIONAL STABILITY WHICH MAY HAVE AIDED IN THE HEALING. OVERALL, THE MEDICAL REVIEWER CONCLUDED THAT THE INITIAL FIXATION PROVIDED STABILITY FOR A PERIOD OF TIME (LIKELY SEVERAL WEEKS), BUT THE PATIENT IS STILL EXPERIENCING TORQUING OF THE PROXIMAL CANAL, SO OVER TIME THE IMPLANT LOOSENED BECAUSE THE FIXATION LACKED ROTATIONAL STABILITY. AFTER SEVERAL WEEKS, DUE TO THE LACK OF ROTATIONAL STABILITY, THE FRACTURE DOESN'T HEAL AND BECOMES PAINFUL DUE TO THE NONUNION. IT IS NOTED THAT BASED ON THE INITIAL X-RAYS AVAILABLE AT THE TIME OF THE MEETING, IT IS UNKNOWN IF THE IMPLANT BROKE AS NO IMAGES OF THE IMPLANT AFTER THE INDEX PROCEDURE BEFORE THE REVISION WERE PROVIDED. IT WAS ALSO NOTED THAT IT IS UNKNOWN IF THIS PATIENT RECEIVED RADIATION THERAPY, WHICH COULD HAVE FURTHER CONTRIBUTED TO THE LACK OF FRACTURE HEALING.

Description of Event or Problem

TWO 15X280MM ILLUMINOSS IMPLANTS WERE IMPLANTED IN THE HUMERUS OF A 70 YEAR OLD ON (B)(6) 2023. SIGNIFICANT BONE LOSS WAS OBSERVED AT THE TIME OF FINAL REDUCTION. AN ADVERSE EVENT OCCURRED ON (B)(6) 2023 FOR PAIN AND/OR LOSS OF FUNCTION, SPECIFICALLY PAIN AND INSTABILITY OF HUMERUS DUE TO PROXIMAL HUMERUS AROUND THE ILLUMINOSS. A RECENT MRI SHOWED NEW LEFT HUMERUS LESIONS WITH SIGNIFICANT PAIN THE HUMERUS AND FEELING THAT IT IS UNSTABLE. AN X-RAY SHOWED DISPLACEMENT OF THE PROXIMAL HUMERUS FRACTURE AROUND THE ILLUMINOSS WHICH WAS IN PLACE AND STABLE IN THE HUMERAL SHAFT. MRI SHOWS LEFT SHOULDER CONCERNING FOR IMPLANT FAILURE. ON (B)(6) 2023 THE FOLLOWING PROCEDURES WERE COMPLETED 1) RESECTION OF LEFT PROXIMAL HUMERUS, APPROXIMATELY 7 CM RESECTION; 2) REMOVAL OF INTRAMEDULLARY PHOTODYNAMIC BALLOON STABILIZING SYSTEM; AND 3) PLACEMENT OF REVERSE TOTAL SHOULDER ARTHROPLASTY WITH PROXIMAL HUMERUS REPLACEMENT WITH A 6 CM PROXIMAL HUMERUS RECONSTRUCTION. THE AE WAS RESOLVED ON (B)(6) 2023.