TRIDENT, RIORecalls & reported problems across all models
Mako Surgical Corp. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 46
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of TRIDENT, RIO by Mako Surgical Corp. in the FDA's device registry (GUDID). Together they are named in 46 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Jul 28, 2025 — classified as 46 malfunctions.
The most frequently reported specific device problem is “Non Reproducible Results” (23 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported TRIDENT, RIO problems
Device problems
- Non Reproducible Results23
- Break21
- Fracture13
- Mechanical Problem10
- Material Integrity Problem7
- Contamination /Decontamination Problem5
- Contamination2
- Difficult to Remove1
Patient problems
- No Known Impact Or Consequence To Patient45
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
TRIDENT, RIO models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TRIDENT, RIO 209830Orthopedic stereotaxic instrument35 reports
- TRIDENT, RIO 209820Orthopedic stereotaxic instrument11 reports
Recent TRIDENT, RIO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2025Residue After Decontamination; Residue After Decontamination
WE ARE HAVING ISSUES WITH THE INLINE OFFSET IMPACTOR. MULTIPLE INCIDENTS OF DEBRIS COMING OUT OF INSIDE IMPACTOR WHEN ATTACHING TO CUP IMPLANT. DEVICE HAS BEEN CLEANED THOROUGHLY WITH NO RESIDUE OR DEBRIS COMING OUT BUT AFTER STERILIZATION, MORE DEBRIS COMES OUT. CASE TYPE / APPLICATION: THA 4.1.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22636751 ↗MalfunctionNov 26, 2019Fracture; Fracture
END OF OFFSET IMPACTOR WHERE IMPACTOR PAD ATTACHES SHEERED OFF DURING IMPACTION. CASE TYPE: THA. SURGICAL DELAY: = 15 MINUTES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9378535 ↗MalfunctionOct 31, 2019Break; Fracture; Break; Fracture
BACK OF STRAIGHT IMPACTION HANDLE SHEARED OFF DURING IMPACTION. CASE TYPE: THA.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9260160 ↗MalfunctionOct 3, 2019Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information
DURING IMPACTION, PHYSICIAN WAS UNABLE TO LOCK PLATFORM INTO PLACE. UPON CLOSER INSPECTION, FOUND STRAIGHT IMPACTOR TO BE BROKEN. CASE TYPE: THA.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9151434 ↗MalfunctionOct 2, 2019Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
INLINE OFFSET IMPACTOR WAS DAMAGED WHILE SURGEON WAS IMPACTING CUP. IMPACTOR PLATE AND HIP END EFFECTOR WERE DAMAGED AS WELL, I HAD A REPLACEMENT SET OF INSTRUMENTS TO OPEN ONTO THE STERILE FIELD, SURGEON HAD DIFFICULTY REMOVING BROKEN INSTRUMENTS OFF OF THE ROBOT, WHICH ADDED TO THE DELAY IN SURGERY. CASE TYPE: THA. SURGICAL DELAY: 35 MINUTES. THIS COMPLAINT IS FOR THE RIO SHELL IMPACT-OFFSET-TRIDENT PST. ASSOCIATED COMPLAINTS FROM THE SAME SURGERY INCLUDE: (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9147805 ↗MalfunctionSep 29, 2019Break; Fracture; Break; Fracture
BROKE WHILE IMPACTING . CASE TYPE: THA. SURGICAL DELAY: 16-30 MINUTES.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9132620 ↗MalfunctionSep 12, 2019Break; Fracture; Break; Fracture
THE END OF THE IMPACTOR SHAFT BROKE OFF. CASE TYPE: THA.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9007959 ↗MalfunctionSep 12, 2019Break; Fracture; Break; Fracture
IT WAS NOTICED THE END OF THE OFFSET IMPACTOR HANDLE WAS BROKEN DURING IMPACTION OF THE CUP. THE IMPACTOR WAS ALREADY BROKEN BEFORE THE CASE, BUT (B)(6) STILL DECIDED TO USE IT. CASE TYPE: THA.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9007943 ↗MalfunctionSep 5, 2019Break; Fracture; Break; Fracture
WENT TO IMPACT CUP, MAKO SHELL IMPACTOR AND OFFSET SHELL IMPACTOR BROKE UPON CONTACT. HIGH VOLUME ACCOUNT NEEDING REPLACEMENT ASAP. CASE TYPE: THA. SURGICAL DELAY: =15 MINUTES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8966876 ↗MalfunctionAug 13, 2019Material Integrity Problem; Non Reproducible Results; Material Integrity Problem; Non Reproducible Results
STRIPPED. CASE TYPE: TKA. UPDATE: "THE PATIENT WAS UNAWARE THAT THE CUP STRIPPED FROM THE IMPACTOR. WE USED A DIFFERENT REAMER. I¿M NOT SURE IF THE SCRUB TECH CROSS THREADED THE CUP OR NOT".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8889391 ↗MalfunctionAug 6, 2019Break; Non Reproducible Results; Break; Non Reproducible Results
THE BACK PART OF THE IMPACTION HANDLE BROKE OFF. CASE TYPE: THA.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8864084 ↗MalfunctionJul 23, 2019Material Integrity Problem; Non Reproducible Results; Material Integrity Problem; Non Reproducible Results
SURGEON HIT THE CUP IMPACTOR ON THE SIDE OF THE PLATE BREAKING THE PLATE AND BENDING THE IMPACTOR. CASE TYPE: THA.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8816996 ↗MalfunctionJul 12, 2019Break; Break
WHILE TAKING OFF STRIKE PLATE PIECE OF IMPACTION HANDLE BROKE OFF. CASE TYPE: THA. UPDATE: PATIENT WAS UNDER ANESTHESIA. WERE ANY DEBRIS/COMPONENTS LEFT INSIDE OF THE PATIENT? "NO". WERE ANY COMPONENTS OF THE DEVICE MISSING OR DISASSEMBLED WHEN THE ISSUE OCCURRED? "NO".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8786430 ↗MalfunctionJul 1, 2019Break; Fracture; Break; Fracture
DURING IMPACTION OF CUP, THE SHAFT OF THE OFFSET IMPACTOR FRACTURED RIGHT AT THE POINT OF CONTACT W/ IMPACTOR PAD. CASE WAS FINISHED ROBOTICALLY, NO OTHER ISSUES. NO DELAYS. NO PT HARM. PICTURES OF THE BREAK WILL BE SENT IN FOLLOWUP EMAIL. IMPACTION WAS SHOWING AT 1MM PROUD SO SURGEON WAS SATISFIED ANYHOW. CASE TYPE: THA. SURGICAL DELAY: MAYBE 1MIN TO LOCATE ALL PIECES AND CONTINUE. UPDATE: "PICS SENT. NO PT INFO PROVIDED - PT NOT AWARE. NO DEBRIS LEFT INSIDE PT. ALL COMPONENTS WERE BUILT OUT CORRECTLY AT THE TIME OF FX OF IMPACTOR SHAFT."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8748273 ↗MalfunctionJun 21, 2019Contamination /Decontamination Problem; Non Reproducible Results; Contamination /Decontamination Problem; Non Reproducible Results
IMPACTOR CONTINUES TO CONTAIN BI BURDEN AFTER STERILIZATION. CASE TYPE: THA; SURGICAL DELAY: X - =15 MINUTES. UPDATE: "YES PATIENT WAS UNDER ANESTHESIA".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8724081 ↗
Other Mako Surgical Corp. products
All Mako Surgical Corp. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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