TRIDENT, RIO 209830Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00848486030285), received between Jun 11, 2018 and Jul 28, 2025 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (16 reports).

4 other recalls cover devices cleared under the same FDA submission (K141989, K170593); they may or may not involve this specific model.

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 25 most recent of 35 reports, 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 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

  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: PATIENT WAS UNDER ANESTHESIA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8724078 ↗
• MalfunctionJun 21, 2019Contamination /Decontamination Problem; Non Reproducible Results; Contamination /Decontamination Problem; Non Reproducible Results

  IMPACTOR CONTAINS BIO BURDEN AFTER STERILIZATION. CASE TYPE: THA. SURGICAL DELAY: =15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8724073 ↗
• MalfunctionMay 24, 2019Material Integrity Problem; Non Reproducible Results; Material Integrity Problem; Non Reproducible Results

  DURING IMPACTION, IMPACTION PLATFORM AND THE BACK ON THE INLINE-OFFSET IMPACTION BROKE. THE PLATFORM CRACKED IN HALF WHILE TAKING A PIECE OF THE BACK OF THE IMPACTOR. IMPACTION WAS STILL COMPLETED WITH THE ROBOT WITH NO PATIENT HARM AND OUTCOMES WERE NOT EFFECTED. CASE TYPE: THA. UPDATE: "NO DEBRIS/COMPONENTS WERE LEFT INSIDE OF THE PATIENT. NO COMPONENTS OF THE DEVICE WERE MISSING OR DISASSEMBLED WHEN THE ISSUE OCCURRED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8642089 ↗
• MalfunctionMay 22, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  WHILE IMPACTING THE CUP ON A MAKO THA, THE IMPACT JON PLATFORM BROKE, AND ALSO BROKE THE OFFSET IMPACTION HANDLE. THE CUP WAS FULLY SEATED WHEN IN BROKE. SO WE CONTINUED ON WITH THE CASE AS NORMAL. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8633310 ↗
• MalfunctionApr 12, 2019Fracture; Non Reproducible Results; Fracture; Non Reproducible Results

  AS REPORTED: "THE IMPACTOR SHAFT END SHEARED OFF INSIDE OF THE IMPACTOR PLATFORM...DURING IMPACTION. THE CASE WAS COMPLETED SUCCESSFULLY." CASE TYPE: THA AS PER THE MPS: "THE IMPACTOR SHAFT WAS THE ONLY ITEM THAT BROKE, IT BROKE INSIDE THE INTACT PLATFORM."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8508319 ↗
• MalfunctionFeb 19, 2019Contamination; Material Integrity Problem; Contamination; Material Integrity Problem

  CLEANING/SPD ISSUE WITH OFFSET IMPACTION HANDLE. BLACK RESIDUE CAME OUT WHEN SURGEON WAS TRYING TO SCREW CUP ON. BECAUSE IT CONTAMINATED THE ENTIRE FIELD, THE SURGEON DEMANDED BOTH HANDLES BE REMOVED IMMEDIATELY AND ARE SET ASIDE AND PACKAGED TO BE SENT BACK. WE WILL NEED TWO OFFSET IMPACTION HANDLES TO REPLACE THE TWO WE WILL BE SENDING BACK. CASE TYPE: THA. SURGICAL DELAY: 15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8351653 ↗
• MalfunctionFeb 19, 2019Contamination; Material Integrity Problem; Contamination; Material Integrity Problem

  CLEANING/SPD ISSUE WITH OFFSET IMPACTION HANDLE. BLACK RESIDUE CAME OUT WHEN SURGEON WAS TRYING TO SCREW CUP ON. BECAUSE IT CONTAMINATED THE ENTIRE FIELD, THE SURGEON DEMANDED BOTH HANDLES BE REMOVED IMMEDIATELY AND ARE SET ASIDE AND PACKAGED TO BE SENT BACK. WE WILL NEED TWO OFFSET IMPACTION HANDLES TO REPLACE THE TWO WE WILL BE SENDING BACK. CASE TYPE: THA. SURGICAL DELAY: 15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8351633 ↗
• MalfunctionFeb 6, 2019Break; Break

  WHEN IMPACTING THE CUP ON THE FINAL HIT... THE END STRIKE PLATE BROKE INTO PIECES AND SNAPPED THE END OFF THE OFFSET CUP IMPACTOR CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8311636 ↗
• MalfunctionJan 14, 2019Break; Fracture; Break; Fracture

  TIP THAT IMPACTION PLATFORM INSERTS INTO, BROKE. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8243560 ↗
• MalfunctionDec 27, 2018Break; Fracture; Break; Fracture

  WHILE DR. (B)(6) WAS USING A MALLET TO IMPACT THE TRIDENT CUP INTO THE PATIENT THE IMPACTION PLATFORM PIECE CRACKED DOWN THE CENTER AND EVENTUALLY BROKE IN HALF ONCE WE REMOVED IT FROM THE INLINE-OFFSET IMPACTION HANDLE. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8200171 ↗
• MalfunctionDec 26, 2018Fracture; Mechanical Problem; Fracture; Mechanical Problem

  OFFSET IMPACTOR IS BROKEN AS IMPACTOR SHELL WOULD NOT COME OFF. PER THE MPS, THE DEVICE BROKE DURING THE CASE. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8196924 ↗
• MalfunctionDec 14, 2018Break; Break

  TAYFUN SIMSEK REPORTED THAT "DURING MAKO TOTAL HIP SURGERY, THE DOCTOR WAS INSTALLING ACETABULAR CUP PROSTHESIS WITH INLINE OFFSET IMPACTOR. THE DOCTOR DECIDED THAT THE CUP WAS INSTALLED FOR AND SAID HE/SHE WOULD BLOW WITH THE MALLET ONE LAST TIME. WHEN THE DOCTOR HIT IMPACTOR WITH THE MALLET AS USUAL, BACK-END OF THE IMPACTOR BROKE. THE DOCTOR REMOVED THE IMPACTOR FROM THE PROSTHESIS IN A TYPICAL MANNER, CONFIRMED THAT THE PROSTHESIS WAS PLACED IN THE PELVIS AND CARRIED THE SURGERY ON"

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8166221 ↗
• MalfunctionDec 14, 2018Fracture; Mechanical Problem; Fracture; Mechanical Problem

  IMPACTOR HANDLE AND IMPACTOR PLATFORM BROKE DURING IMPACTION. CASE TYPE: THA. SURGICAL DELAY =15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8163877 ↗
• MalfunctionDec 13, 2018Break; Break

  OFFSET IMPACTION HANDLE AND IMPACTION PLATFORM BOTH BROKE UPON IMPACTION. CASE TYPE: THA, SURGICAL DELAY- =15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8161731 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141989, K170593. One submission often covers many models, so check the product and lot details in each record.

• Z-2745-2020 · Jul 9, 2020 · Terminated
  Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
• Z-3182-2018 · Dec 27, 2017 · Terminated
  Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated fo
• Z-3131-2017 · Aug 7, 2017 · Terminated
  Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries f
• Z-1411-2017 · Dec 22, 2016 · Terminated
  MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.