ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THE SURGEON QUESTIONED THE ALIGNMENT ON POST OP X-RAY GIVEN THE PLANNED AND VALIDATED CUTS MEASURED DO NOT CORRELATE. PLANNED FOR NEUTRAL TO SLIGHT VALGUS KNEE OVERALL, STARTED AT 18 DEG VALGUS. VALIDATED CUTS SUGGEST WE SHOULD HAVE ENDED UP AT NEUTRAL OR CLOSE TO HOWEVER ON POST OP X-RAYS HAVE ENDED AT 10 DEG VARUS. THE PATIENT HAS ALSO REPORTED SIGNS OF PAIN AND INSTABILITY. THE PATIENT IS BEING CONSIDERED FOR A REVISION. NO ADDITIONAL INFORMATION.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A TKA ROBOTIC ASSISTED SURGERY THE POSTERIOR RESECTION WAS 4.5MM MORE THAN PLANNED ON BOTH SIDES, RESULTING IN AN UNEQUAL BALANCE BETWEEN EXTENSION AND FLEXION AND THE USE OF A THICKER POLY. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED TKA THE TIBIA WAS OVER RESECTED BY 3 MM. DUE TO THIS DISCREPANCY, A 16MM POLY INSERT WAS USED INSTEAD OF THE PLANNED 13MM INSERT. NO ADDITIONAL PATIENT IMPACT HAS BEEN REPORTED OTHER THAN THE DEVIATION FROM PLANNED IMPLANT SIZE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A TKA PROCEDURE USING ROSA KNEE INSTRUMENTATION, THE PATIENT'S PROXIMAL TIBIA WAS OVER-RESECTED AND THE 4-IN-1 POSTERIOR FEMUR WAS UNDER RESECTED. THIS LEAD TO AN ANTERIOR FEMUR NOTCH, ALTHOUGH IT WAS WARNED AS POTENTIALLY AN ISSUE. SURGEON DECIDED TO PROCEED. ALL BONE CHIPS WERE CALIPERED. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT FOLLOWING A TKA DONE BY ROSA KNEE SURGICAL INSTRUMENTATION, FEMORAL NOTCHING WAS NOTICED IN THE POST OPERATIVE X-RAYS. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT HAS BEEN REPORTED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A TKA SURGERY WITH ROSA INSTRUMENTATION, THE DISTAL FEMUR CUT WAS VALIDATED 3MM OVER THE PLANNED RESECTION. THE CUT WAS VALIDATED USING ROSA AND STANDARD CALIPERS. DUE TO THIS OVER-RESECTION OF THE DISTAL FEMUR, THE SURGEON DOWNSIZED BY 2 SIZES TO BALANCE THE SPACE. NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE ROSA PLATFORM DURING A TKA SURGERY, THERE WAS AN OVER RESECTION OF TIBIA BY 3MM. A THICKER THAN EXPECTED POLY IMPLANT HAD TO BE USED. NO ADDITIONAL CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.