Description of Event or Problem · 0
THIS EVENT REGARDS AN AMPUTATION AFTER A CUSTOM MADE IMPLANT. THE DESIGNED CUSTOM DEVICES, BASED ON THE PATIENT AND ORDER PHYSICIAN NEED, WERE TWO CUSTOM MADE COLLARS WITH POROUS SURFACES. THE FIRST ONE HAD A CYLINDRICAL CONTACT SURFACES AMD THE SECOND OPTION HAD AN ANATOMICAL CONTACT SURFACES (TITANIUM). THE STEM WAS MADE COMPATIBLE WITH IMPLANT GMRS. ALL COMPONENTS WERE MADE OF COMMONLY USED MATERIALS FOR KNEE PROSTHESES COMMERCIALLY AVAILABLE IN THE US. THE CUSTOM-MADE IMPLANT WAS REQUIRED AFTER PREVIOUS PTR HAD FAILED. THROUGH CT IMAGES, THE SPECIFIC CUSTOM DEVICE HAS BEEN DESIGNED IN ORDER TO RESPOND TO THE SPECIFIC ANATOMICAL CHARACTERISTICS OF THE PATIENT'S TIBIA FOLLOWING THE FAILED PTR. THE IMPLANTATION WAS DONE IN (B)(6) 2023, THEN THE PROSTHESIS HAS BEEN IMPLANTED FOR ABOUT 2 YEARS. THE PROSTHESIS AT THE TIME OF THE RE-INTERVENTION WAS NOT OSTEOINTEGRATED, BEING ABLE TO MOVE MACROSCOPICALLY WITH RESPECT TO THE BONE. AT THE MOMENT, WE DO NOT KNOW IF THERE WAS ALSO A FRACTURE OF THE BONE. THE CAUSE OF FAILURE TO OSTEOINTEGRATE COULD BE MECHANICAL (ASEPTIC) IN NATURE DUE TO EXCESSIVE MECHANICAL STRESS APPLIED TO THE (POOR) BONE-PROSTHESIS INTERFACE OR INFECTION (SEPTIC). FROM THE INFORMATION COLLECTED IT IS NOT POSSIBLE TO UNDERSTAND WHICH OF THE TWO IS THE REAL CAUSE. THE INVESTIGATION IS STILL ONGOING.