Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DIAGNOSED WITH SEVERE ARTHRITIS IN LEFT KNEE AND HAD A TOTAL KNEE REPLACEMENT ON (B)(6) 2020. THE SURGEON USED THE STRYKER TRIATHLON AND MAKO NAVIGATION SYSTEM. I NEVER FULLY RECOVERED, AND HAD SEVERE INSTABILITY WITH EXTENSIVE PAIN AND SWELLING THAT WORSENED APPROXIMATELY 4 MONTHS POST SURGERY. DESPITE EXTENSIVE PHYSICAL THERAPY, I NEEDED TO HAVE REVISION SURGERY ON (B)(6) 2022. THE SURGEON CONFIRMED GLOBAL INSTABILITY OF THE KNEE, WITH MECHANICAL LOOSENING OF THE PROSTHETIC. A 13 MM POLYETHYLENE INSERT WAS INSTALLED TO REPLACE THE ORIGINAL 9 MM INSERT. TWO YEARS SINCE THE REVISION SURGERY I CONTINUE TO HAVE SWELLING AND PAIN, WITH SOME RESIDUAL INSTABILITY THAT IS CAUSING OTHER SOFT TISSUE INFLAMMATION IN MY LEG. I HAVE BEEN FORCED TO USE AN EXTERNAL KNEE BRACE TO ADDRESS THE INSTABILITY AND HAVE HAD A SPINAL STIMULATOR IMPLANTED TO ASSIST WITH THE PAIN. I RECENTLY RECEIVED ANOTHER SPECIALIST DIAGNOSIS ON (B)(6) 2024 INDICATING THAT I HAVE FLEXION AND EXTENSION MISMATCH THAT IS DUE TO OVER RESECTION OF THE POSTERIOR FEMUR IN THE FIRST SURGERY. IT IS MY UNDERSTANDING THAT THE STRYKER IMPLANT WHEN USED WITH THE MAKO NAVIGATION SYSTEM DOES NOT ALLOW OVER RESECTION OF BONE TO OCCUR,

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: STRYKER REP DID NOT SHOW UP FOR CASE. A CEMENTLESS MAKO BILATERAL KNEE PLANNED AND ONLY THE MPS REP WAS PRESENT BECAUSE STRYKER JOINT REP WAS TOO BUSY TO COVER. A CEMENTED TKA IMPLANT WAS GIVEN BY REP AND IMPLANTED IN LEFT KNEE AND ONLY NOTED BY REP WHILE DOING INVENTORY WHEN RIGHT KNEE WAS BEING CLOSED. NOBODY NOTICED IT. WHEN I IMPLANTED IT, I RECALL I CONFIRMED THE SIZES AND OFTEN WE TRUST THE REPS TO SHOW US THE CORRECT IMPLANTS AND THE SIZES AND CORRECT SIDE WERE IDENTIFIED. THE MAKO CUT IS ALWAYS GOOD SO THE FIT OF THE IMPLANT WAS SNUG. SO I DID NOT SUSPECT A PROBLEM. WHEN THE SCRUB HANDS ME THE IMPLANT, IT IS HANDED TO ME LOADED ON THE JIG INTO MY HANDS READY TO MALLET IN PLACE AND WAS TAKEN WITH THE BACKSIDE FACING OPPOSITE ME AND THEN TURNED TOWARDS THE CUT FEMUR AND HAMMERED IN. THAT IMPLANT SHOULD NEVER HAVE BEEN HANDED TO THE STERILE FIELD. A BENEFIT RISK DECISION WAS MADE BY ME TO LEAVE THE IMPLANT IN PLACE BECAUSE I ONLY FOUND OUT AT THE END OF THE 2ND KNEE (RIGHT KNEE CLOSING) AND DUE TO NUMEROUS SURGICAL DELAYS, THE OPERATIVE TIME WAS TOO HIGH TO WARRANT OPENING A WELL SEATED IMPLANT - IT WAS FELT THAT A GOOD FITTING IMPLANT WOULD DO WELL EVEN WITH A FIBROUS UNION I

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S RIGHT KNEE WAS REVISED. A 2X11 TS INSERT WAS IMPLANTED. UPDATE (B)(6)2020 WG: SALES BRANCH PROVIDED THE PRIMARY USAGE SHEET. A 2X9 TS INSERT WAS REVISED TO A 2X11 TS INSERT. UPDATE: "PATIENT WAS TREATED WITH I&D DUE TO ACUTE INFECTION. X-RAYS/REMOVED POLYETHYLENE ARE NOT AVAILABLE."

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE DOCTOR PERFORMED AN I&D INSERT SWAP ON A PATIENT DUE TO INFECTION OF A MAKO RIGHT MEDIAL UNI. ORIGINAL DOS WAS (B)(6) 2020.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR. PERFORMED AN I&D AND INSERT SWAP ON THE RIGHT MEDIAL MAKO UNI DUE TO INFECTION.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON OR ABOUT (B)(6) 2020, A MAKO TOTAL KNEE WITH TRIATHLON WAS IMPLANTED INTO THE PATIENT'S RIGHT KNEE USING PRODUCT/ROBOTIC ASSISTANCE, PINNING THE PRODUCT TO THE PATIENT'S FEMUR. IT IS FURTHER ALLEGED THAT ON OR ABOUT (B)(6) 2020, THE PATIENT'S FEMUR BROKE AS A DIRECT RESULT OF THE PRODUCT AND IMPLANTATION, AND HE UNDERWENT SUBSEQUENT SURGERY AS A RESULT OF HIS INJURIES.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MAKO ROBOTIC EQUIPMENT MADE INCORRECT POSTERIOR CHAMBER CUT DURING SURGERY. FDA SAFETY REPORT ID# (B)(4).