RIO 112227Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00848486017446), received between Sep 28, 2018 and Aug 3, 2022 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2022Break; Incorrect, Inadequate or Imprecise Result or Readings; Break; Incorrect, Inadequate or Imprecise Result or Readings

  DURING DISTAL CUT (1ST CUT PERFORMED), THE CUTTER SHIFTED GOING FROM THE LATERAL TO MEDIAL SIDE CUTTING THE MEDIAL SIDE DEEPER. THE SURGEON STOPPED AND SAID IT DIDN¿T LOOK RIGHT SO WE PULLED OUT THE CUTTER AND CHECKED THE FEMUR AND CUTTER. THE FEMUR WAS FINE BUT THE CUTTER REGISTERED AT 7.5MM. WE CHECKED DISCS AND THE BASE ARRAY AND EVERYTHING LOOKED FINE SO WE REREGISTERED AND PLACED A NEW DISTAL ATTACHMENT AND SAW BLADE. WE PASSED AGAIN GETTING INTO THE BONE PREP SCREEN FOR THE DISTAL CUT AND THE SAME ISSUE OCCURRED. THE SURGEON ASKED FOR MANUAL INSTRUMENTATION AND TO REMOVE THE ROBOT. UPON INSPECTING EVERYTHING, THE BASE ARRAY ITSELF LOOKS TO BE THE ISSUE. IT DOES NOT FASTEN SECURELY BECAUSE THE SPRING MECHANISM IS BROKEN. CAN I PLEASE HAVE AN FSE ALSO COME LOOK AT THE ROBOT TO ENSURE IT IS WORKING PROPERLY? SURGICAL DELAY = 15 MINUTES. TOURNIQUET USED. UPDATE ON 13/JULY/2022 WG: AS REPORTED VIA CASE NUMBER: (B)(4): MPS REPORTED INACCURATE CUTS. ON A TKA CASE, DISTAL CUT WAS NOTICEABLY OFF BY ABOUT 5MM. BASE ARRAY WAS LOSE AND J2 BUMP STOPS WERE OFF. (B)(4): DETAILED MAINTENANCE INSPECTION PERFORMED. ADJUSTED AND CALIBRATED J2 BUMP STOP SHOCK ABSORBERS PER MANUAL. VERIFIED ARM A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15160408 ↗
• MalfunctionJul 13, 2021Difficult to Insert; Residue After Decontamination; Difficult to Insert; Residue After Decontamination

  BLUE PROBE- FAILED PROBE CHECK AT 1.5MM. BASE ARRAY- BASE ARRAY POST WAS STIFF AND DIFFICULT TO COMPRESS, THERE SEEMED TO BE STICKY RESIDUE ON THE POST AND AFTER CLEANING IT STILL WAS DIFFICULT TO PROPERLY ATTACH TO THE ROBOT. SURGICAL DELAY: = 15 MINUTES. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160959 ↗
• MalfunctionOct 19, 2020Residue After Decontamination; Residue After Decontamination

  RESIDUE AT POST OF BASE ARRAY. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10697498 ↗
• InjuryAug 26, 2020Break; Positioning Failure; Break; Positioning Failure

  BASE ARRAY WAS HIT, CAUSED ANTERIOR CUT TO BE DEEP. NOTCHED FEMUR, HAD TO STEM FEMUR. CASE TYPE: TKA. SURGICAL DELAY = 16-30 MINUTES.

  Patient problems: Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 10457072 ↗
• MalfunctionDec 27, 2019Positioning Failure; Positioning Failure

  DURING SURGERY, THE ROBOT HAD TO BE RE-REGISTERED PRIOR TO CUTS BEING MADE. AFTER RE- REGISTRATION OCCURRED, THE ROBOT PASSED THE CHECK POINT AND WE PROCEEDED TO CUTS. WHILE THE SURGEON WAS MAKING THE DISTAL FEMORAL CUT, THE ROBOT KEPT CUTTING OUT, AND THEN MADE A DEEPER CUT THAN PLANNED. THE SURGEON ABANDONED USING THE ROBOT AND SWITCHED TO MANUAL. UPON INVESTIGATION, IT WAS NOTICED THAT THE TAB THAT LOCKS THE BASE ARRAY IN PLACE HAD BROKEN OFF AND THE BASE ARRAY WAS SPINNING IN THE MOUNT. SEE PICTURES. CASE TYPE: TKA SURGERY WAS NOT COMPLETED ROBOTICALLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9528267 ↗
• MalfunctionDec 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  BROKEN BASE ARRAY TILTED. CASE TYPE: TKA. SURGICAL DELAY: 30 MINUTES. UPDATE: WERE ANY DEBRIS/COMPONENTS LEFT INSIDE OF THE PATIENT? (YES/NO) NO. WERE ANY COMPONENTS OF THE DEVICE MISSING OR DISASSEMBLED WHEN THE ISSUE OCCURRED? (YES/NO) NO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9396775 ↗
• MalfunctionOct 31, 2019Output Problem; Output Problem

  CASE NUMBER: (B)(4), ROB523: MPS, TARA BRETT, REPORTED ROBOT OFF CUTTING TO 5MM DEEP. REVERTED TO MANUAL. CASE TYPE: TKA. SURGICAL DELAY: 5 HOURS. SURGERY WAS NOT COMPLETED ROBOTICALLY. UPDATE: "WAS THERE PATIENT INVOLVEMENT? ANY PATIENT HARM? YES NEED TO REVERT TO MANUAL AND USE 5MM DISTAL AUGMENTS. ANY SURGICAL DELAY? 5HOURS. WAS THE CASE CANCELLED? NO. WAS PROCEDURE COMPLETED SUCCESSFULLY? YES BUT NOT TO PLAN. WAS PROCEDURE COMPLETED MANUALLY? YES. WAS THE PATIENT UNDER ANESTHESIA AT THE TIME OF THE ISSUE? YES. WHICH CUTS WERE INACCURATE? ONLY ONE CUT PREFORMED AND THE DISTAL FEMUR. HOW WAS THE CUT INACCURATE? 5MM DEEP. WHAT IS THE ESTIMATED DISCREPANCY MENTIONED IN THE COMPLAINT? (PKA - MM) 5MM WHEN WAS THE ISSUE NOTICED? BONE PREPARATION. WAS THE PLANAR PROBE UTILIZED TO MEASURE CUT ACCURACY? YES. ARE POST-OP X-RAYS AVAILABLE? NO."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9260158 ↗
• MalfunctionOct 15, 2019Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

  THE ROBOT KEEP FLICKERING ON THE SCREEN, AND REALIZED THE VISA DISC WASN¿T SITTING FLUSH DUE TO A BENT PRONG. CASE TYPE: TKA. PATIENT UNDER ANESTHESIA. SURGICAL DELAY: 16-30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9191858 ↗
• MalfunctionOct 15, 2019Detachment of Device or Device Component; Output Problem; Detachment of Device or Device Component; Output Problem

  ON OUR SECOND MAKO TKA CASE OF THE DAY. THE SURGEON WENT TO CUT THE DISTAL FEMUR, THE SAW CHECK POINT WAS OFF. THE MICS GOT CONTAMINATED SO HAVE TO PUT A NEW ONE ON. THEN WE RE-DONE RIO REGISTRATION. ALL CHECK POINTS PASSED WE WENT TO CUT THE LATERAL CONDYLE WHICH WAS FINE AND WHEN HE CUT THE MEDIAL SIDE HE NOTICED IT CUT 2 DIFFERENT PLANES. CHECKED IT WITH A PLANOR PROBE AND IT SAID 2MM DEEP. THE SURGEON WANTED TO MAKE THESE A STRAIGHT CUT SO PROXIAMLISED THE FEMUR TO CUT HE LATERAL THE CORRESPONDING 2MM TO MAKE IT A STRAIGHT CUT. WENT BACK IN ALL CHECK POINTS PASSED HE NOTICED AGAIN THE ROBOT WAS CUTTING ON 2 DIFFERENT PLANES. THIS TIME IT WAS 5MM DEEP WITH THE PLANOR PROBE. AT THIS POINT HE LOST HIS TRUST IN THE ROBOT AND HAD TO REVERT TO A MANUAL CASE. HE NEEDED DISTAL FEMUR AUGMENTS TO CORRECT THIS PROBLEM BUT UNFORTUNATELY THE NEAREST ONES WERE 3 HOURS AWAY. HE WAITED WITH PATIENT ON THE TABLE FOR IMPLANTS TO ARRIVE. SURGICAL DELAY: DELAY OF 5 HOURS PATIENT HAD AND EXTENDED ANAESTHETIC AND HIGH RISK OF INFECTION. UPDATE: THE STRYKER FIELD SERVICE ENGINEER RE-CALIBRATED THE ROBOT AND REPORTED THAT THE ISSUE WAS DUE TO A DAMAGED BASE ARRAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9191242 ↗
• MalfunctionAug 15, 2019Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  UPON BEGINNING OF CUTTING SEQUENCE, SAW AND FEMORAL CHECKPOINT BOTH PASSED, ADVANCED TO FEMORAL DISTAL CUT AND LATERAL FEMUR CUT WAS FINE AND THEN SAW BEGAN TO DRIFT OFF BONE AND DID NOT MAKE A MEDIAL DISTAL CUT. VERIFIED THAT BOTH TIBIAL AND FEMORAL ARRAYS WERE STILL ACCURATE. RE-REGISTERED MAKO ROBOT AND WENT BACK TO CUTTING PAGE, BOTH ROBOT AND FEMORAL CHECKPOINTS PASSED AND CONTINUED ONTO RECUTTING DISTAL FEMUR. AGAIN, SAW DRIFTED. CHECKED BASE ARRAY AND IT WAS LOSE AND WAS MISSING A PRONG THAT LOCKS IT IN. EXCHANGED FOR ANOTHER ONE RE-REGISTERED ROBOT AND CONTINUED TO CUT DISTAL FEMUR. COMPLETED SURGERY SUCCESSFULLY. CASE TYPE: TKA. SURGICAL DELAY: 10 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8898803 ↗
• InjuryMay 2, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  IT WAS REPORTED BY THE DISTRIBUTOR THAT THE BASE ARRAY WAS INSTALLED BY THE NURSE ON THE ROBOT. DURING INSTALLATION, A NOISE WAS HEARD (ONE OF THE PINS ON THE BASE ARRAY MAY HAVE BEEN BROKEN AT THAT TIME), BUT AT THAT POINT THE NURSE CONFIRMED THAT IT WAS STABLE. INTRAOPERATIVELY, IT WAS DISCOVERED BY THE SURGEON THAT THE BASE ARRAY WAS MOVING, WHICH CAUSED INACCURACY IN THE BONE PREPARATION, RESULTING IN OVER REMOVAL OF THE FEMUR BONE WHICH HE HAD TO EVENTUALLY CONVERT TO A TOTAL KNEE REPLACEMENT DUE TO THAT. POST OPERATIVELY, IT WAS DISCOVERED THAT A PIN FROM THE BASE ARRAY WAS BROKEN WHICH CAUSED THE INSTABILITY, LEADING TO INACCURATE BONE REMOVAL. UPDATE: 1. WAS CASE WAS CONVERTED FROM A PKA TO A TKA BASED ON THE EVENT?. YES. UPDATE: RIGHT SIDE. SURGICAL PROCEDURE COMPLETED MANUALLY.

  Patient problems: No Known Impact Or Consequence To Patient; Tissue Damage

  MAUDE report 8573855 ↗
• MalfunctionSep 28, 2018Break; Fracture; Break; Fracture

  THE BASE ARRAY MAY BE BENT. I COULD NOT GET THE CUTTER CHECK TO PASS DURING A TKA PROCEDURE. WE CHANGED OUT THE BASE ARRAY EVENTUALLY AND WERE ABLE TO PASS. THERE WAS A THIRTY MINUTE DELAY IN SURGERY YES PATIENT WAS UNDER ANESTHESIA DON'T HAVE IDENTIFIER. THIS WAS A TKA PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7920124 ↗