Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING INFORMATION WAS PROVIDED: I&D OF RIGHT KNEE WITH MEDIAL UNI POLY SWAP OUT 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: THE FOLLOWING INFORMATION WAS PROVIDED: I&D OF A LM PKA WITH AN MCK TIBIAL INSERT EXCHANGE 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: REVISED A LEFT MEDIAL TIBIAL INSERT DUE TO A FLOATING LOOSE BODY THAT CAUSED THE PATIENT PAIN. REMOVED THE LOOSE BODY AND PUT A NEW TIBIAL INSERT IN. NO ALLEGATIONS AGAINST THE IMPLANT MADE.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PT (PATIENT) HAD HARDWARE PLACED (B)(6) 2021 AND ON FOLLOW UP X-RAY, CT (COMPUTED TOMOGRAPHY) AND MRI (MAGNETIC RESONANCE IMAGING) REVEALED THE BACKING OUT OF THE SCREWS AT C5 LEVEL AS WELL AS A BROKEN LOCKING MECHANISM. (B)(6) 2023: PT HAD SURGERY: REVISION ANTERIOR CERVICAL APPROACH REMOVAL OF OLD HARDWARE REVISION OF C4-5 FUSION RE INSTRUMENTATION FROM C3 TO C5 THE CAGES USED (B)(6) 2021 WERE: 1. IMPLANT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE 2. IMPLANT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE (LOOKS LIKE THEY USED THE SAME SIZE CAGES FOR BOTH LEVELS) THE PLATE USED WAS: PLATE 2 LEVEL OZARK VIEW 40MM ¿ SNONE THE SCREWS USED WERE: SCREW VARI SELF-START OZARK 4X16MM ¿ SNONE (THERE WERE MOST LIKELY 6 SCREWS, LOOKS LIKE ALL WERE SAME SIZE) COMPANY AT THE TIME OF INITIAL SURGERY IN 2021 IS K2M- COMPANY NAME CHANGED TO STRYKER. REFERENCE REPORTS: MW5120510 AND MW5120512.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PT (PATIENT) HAD HARDWARE PLACED (B)(6) 2021 AND ON FOLLOW UP X-RAY, CT (COMPUTED TOMOGRAPHY) AND MRI (MAGNETIC RESONANCE IMAGING) REVEALED THE BACKING OUT OF THE SCREWS AT C5 LEVEL AS WELL AS A BROKEN LOCKING MECHANISM. (B)(6) 2023: PT HAD SURGERY: REVISION ANTERIOR CERVICAL APPROACH REMOVAL OF OLD HARDWARE REVISION OF C4-5 FUSION RE INSTRUMENTATION FROM C3 TO C5 THE CAGES USED (B)(6) 2021 WERE: 1. IMPLANT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE 2. IMPLNT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE (LOOKS LIKE THEY USED THE SAME SIZE CAGES FOR BOTH LEVELS) THE PLATE USED WAS: PLATE 2 LEVEL OZARK VIEW 40MM ¿ SNONE THE SCREWS USED WERE: SCREW VARI SELF-START OZARK 4X16MM ¿ SNONE (THERE WERE MOST LIKELY 6 SCREWS, LOOKS LIKE ALL WERE SAME SIZE) COMPANY AT THE TIME OF INITIAL SURGERY IN 2021 IS K2M- COMPANY NAME CHANGED TO STRYKER. REFERENCE REPORTS: MW5120511 AND MW5120512.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PT (PATIENT) HAD HARDWARE PLACED (B)(6) 2021 AND ON FOLLOW UP X-RAY, CT (COMPUTED TOMOGRAPHY) AND MRI (MAGNETIC RESONANCE IMAGING) REVEALED THE BACKING OUT OF THE SCREWS AT C5 LEVEL AS WELL AS A BROKEN LOCKING MECHANISM. (B)(6) 2023: PT HAD SURGERY: REVISION ANTERIOR CERVICAL APPROACH REMOVAL OF OLD HARDWARE REVISION OF C4-5 FUSION RE INSTRUMENTATION FROM C3 TO C5 THE CAGES USED (B)(6) WERE: 1. IMPLANT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE 2. IMPLANT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE (LOOKS LIKE THEY USED THE SAME SIZE CAGES FOR BOTH LEVELS) THE PLATE USED WAS: PLATE 2 LEVEL OZARK VIEW 40MM ¿ SNONE THE SCREWS USED WERE: SCREW VARI SELF-START OZARK 4X16MM ¿ SNONE (THERE WERE MOST LIKELY 6 SCREWS, LOOKS LIKE ALL WERE SAME SIZE) COMPANY AT THE TIME OF INITIAL SURGERY IN 2021 IS K2M- COMPANY NAME CHANGED TO STRYKER. REFERENCE REPORTS: MW5120510 AND MW5120511.

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 REVISED A MAKO TIBIAL INSERT THAT WAS ORIGINALLY DONE BY DR. ON (B)(6) 2021 DUE TO INFECTION. RIGHT KNEE.

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 WITH TIBIAL INSERT EXCHANGE DUE TO POSSIBLE INFECTION OF A LEFT MEDIAL UNI.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A MAKO PKA CASE AN INCORRECT SIZE 3 POLY INSERT WAS IMPLANTED ONTO A SIZE 4 TIBIAL BASEPLATE. THE ERROR WAS DISCOVERED BY THE SURGEONS REG AFTER THE PATIENT HAD JUST BEEN CLOSED. THE PATIENT WAS REOPENED AND THE CORRECT SIZE 4 POLY INSERTED. PROBLEM RESOLVED. NO NEW SPINAL OR GA WAS NEEDED.

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 THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S RIGHT MAKO PKA DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A SPACER WAS PLACED. REP PROVIDED THE PRIMARY IMLANT SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

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).

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PATIENT HAD A RIGHT MAKO THA SURGERY ON (B)(6) 2019. SHE STARTED TO EXPERIENCE DRAINAGE FROM INCISION APPROX. (B)(6) 2019. THE INCISION OPENED ON (B)(6) 2019, PATIENT WENT TO THE ER AND WAS ADMITTED. PATIENT WAS PARTIALLY REVISED ON (B)(6) 2019. PATIENT WAS DISCHARGED A WEEK AFTER REVISION AND WAS GIVEN ANTIBIOTICS. ON (B)(6) 2019 PATIENT WENT FOR A FOLLOW-UP VISIT AND WAS TOLD TO FOLLOW UP WITH HER ORIGINAL SURGEON. PATIENT WENT TO SEE THE ORIGINAL SURGEON THE SAME DAY AND WAS ADMITTED TO THE HOSPITAL. DURING HER HOSPITAL STAY, MULTIPLE I&DS WERE PERFORMED APPROX. (B)(6) 2019, (B)(6) 2019 AND ON (B)(6) 2019. PATIENT WAS DISCHARGED ON (B)(6) 2019. PATIENT CONTINUED TO EXPERIENCE DRAINAGE AFTER BEING DISCHARGED. ALL COMPONENTS WERE REVISED ON (B)(6) 2019 AND A CEMENT SPACER WAS PLACED. ANOTHER I&D WAS PERFORMED ON (B)(6) 2019 AND WAS PLACED IN REHAB. ON (B)(6) 2019 THE SPACER WAS REMOVED, AND PATIENT WAS IMPLANTED WITH COMPETITOR PRODUCT. THIS PI IS FOR MULTIPLE I&D¿S WHILE HOSPITALIZED.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PATIENT HAD A RIGHT MAKO THA SURGERY ON (B)(6) 2019. SHE STARTED TO EXPERIENCE DRAINAGE FROM INCISION APPROX. (B)(6) 2019. THE INCISION OPENED ON (B)(6) 2019, PATIENT WENT TO THE ER AND WAS ADMITTED. PATIENT WAS PARTIALLY REVISED ON (B)(6) 2019. PATIENT WAS DISCHARGED A WEEK AFTER REVISION AND WAS GIVEN ANTIBIOTICS. ON (B)(6) 2019 PATIENT WENT FOR A FOLLOW-UP VISIT AND WAS TOLD TO FOLLOW UP WITH HER ORIGINAL SURGEON. PATIENT WENT TO SEE THE ORIGINAL SURGEON THE SAME DAY AND WAS ADMITTED TO THE HOSPITAL. DURING HER HOSPITAL STAY, MULTIPLE I&DS WERE PERFORMED APPROX. ON (B)(6) 2019, (B)(6) 2019 AND ON (B)(6) 2019. PATIENT WAS DISCHARGED ON (B)(6) 2019. PATIENT CONTINUED TO EXPERIENCE DRAINAGE AFTER BEING DISCHARGED. ALL COMPONENTS WERE REVISED ON (B)(6) 2019 AND A CEMENT SPACER WAS PLACED. ANOTHER I&D WAS PERFORMED ON (B)(6) 2019 AND WAS PLACED IN REHAB. ON (B)(6) 2019 THE SPACER WAS REMOVED, AND PATIENT WAS IMPLANTED WITH COMPETITOR PRODUCT. THIS PI IS FOR REVISION OF 1ST REVISION.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS PI IS FOR REVISION OF PRIMARY. PATIENT HAD A RIGHT MAKO THA SURGERY ON (B)(6) 2019. SHE STARTED TO EXPERIENCE DRAINAGE FROM INCISION APPROX. (B)(6) 2019. THE INCISION OPENED ON (B)(6) 2019, PATIENT WENT TO THE ER AND WAS ADMITTED. PATIENT WAS PARTIALLY REVISED ON 2019. PATIENT WAS DISCHARGED A WEEK AFTER REVISION AND WAS GIVEN ANTIBIOTICS. ON (B)(6) 2019 PATIENT WENT FOR A FOLLOW-UP VISIT AND WAS TOLD TO FOLLOW UP WITH HER ORIGINAL SURGEON. PATIENT WENT TO SEE THE ORIGINAL SURGEON THE SAME DAY AND WAS ADMITTED TO THE HOSPITAL. DURING HER HOSPITAL STAY, MULTIPLE I&DS WERE PERFORMED APPROX. (B)(6) 2019, (B)(6) 2019 AND ON (B)(6) 2019. PATIENT WAS DISCHARGED ON (B)(6) 2019. PATIENT CONTINUED TO EXPERIENCE DRAINAGE AFTER BEING DISCHARGED. ALL COMPONENTS WERE REVISED ON (B)(6) 2019 AND A CEMENT SPACER WAS PLACED. ANOTHER I&D WAS PERFORMED ON (B)(6) 2019 AND WAS PLACED IN REHAB. ON (B)(6) 2019 THE SPACER WAS REMOVED, AND PATIENT WAS IMPLANTED WITH COMPETITOR PRODUCT.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON NOTICED A FEMUR DURING PRIMARY TKA.

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 THAT PATIENT'S RIGHT MEDIAL KNEE WAS REVISED TO A PS TOTAL KNEE DUE TO PAIN AND OSTEOARTHRITIS.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PATIENT HAD A MAKO UNI AND PATELLA FEMORAL REPLACEMENT ON (B)(6) 2017 AND RECENTLY PRESENTED WITH PERSISTENT PAIN. DOCTOR REMOVED IMPLANTS AND REVISED WITH A TOTAL KNEE.

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 THAT PATIENT'S LEFT MAKO UNICOMPARTMENTAL KNEE WAS REVISED DUE TO MCL INSTABILITY.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON DID AN I&D WITH AN INSERT SWAP OF THE LEFT KNEE DONE AS A MAKO MEDIAL ORIGINALLY ON (B)(6) 2017.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A SIZE 5X9MM ONLAY TIBIAL INSERT WAS INSERTED ON A SIZE 6 TIBIAL BASE PLATE. UPDATE AS PER SALES RESPONSE RECEIVED ON 09-DEC-2016: "REASON FOR REVISION WAS: SURGEON PUT A 5X9 POLY ON A SIZE 6 TIBIA BASE PLATE. IT WAS NOT PRODUCT ERROR. THE 5X9MM WAS REMOVED AND A 6X9MM WAS PUT IN PLACE."

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MAKO ROBOT BY STRYKER ORTHO FAILED. THE SENSORS STOPPED COMMUNICATING WITH THE COMPUTER. THIS HAPPENED AFTER BEGINNING A SURGERY FOR A KNEE REPLACEMENT. THE HOSPITAL HAD TO CALL IN ANOTHER COMPANY TO USE THEIR INSTRUMENTS AND IMPLANTS INSTEAD OF THE MAKO/STRYKER WHICH COULD NOT BE FIXED AFTER 15 MINUTES OF FAILED ATTEMPTS IN THE OPERATING ROOM.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON REVISED LEFT MAKO KNEE DUE TO PAIN AND INFECTION.