TRIDENT, RIO 209820Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00848486030278), received between Dec 5, 2018 and Oct 31, 2019 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

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

  IMPACTOR CONTINUES TO CONTAIN BIO BURDEN AFTER STERILIZATION. CASE TYPE: THA. SURGICAL DELAY: 15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8724076 ↗
• MalfunctionJun 21, 2019Contamination /Decontamination Problem; Non Reproducible Results; Contamination /Decontamination Problem; Non Reproducible Results

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8723982 ↗
• MalfunctionMay 30, 2019Break; Break

  THE END OF THE MAKO STRAIGHT CUP IMPACTOR BROKE OFF INSIDE OF THE IMPACTION PLATFORM. CASE TYPE: THA. UPDATE: "YES THE IMPACTOR BROKE DURING IMPACTION".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8653509 ↗
• MalfunctionFeb 14, 2019Mechanical Problem; Non Reproducible Results; Mechanical Problem; Non Reproducible Results

  AFTER THE CUP WAS FULLY IMPACTED DR. ALI HAD A LOT OF DIFFICULTY UNSCREWING THE CUP FROM THE IMPACTION HANDLE. UPON REMOVAL I NOTICED THE THREADS WERE DAMAGED CAUSING THE CUP TO CROSS THREAD. CASE TYPE: (B)(4). SURGICAL DELAY: SEVERAL MINUTES ATTEMPTING TO UNSCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8340946 ↗
• MalfunctionJan 3, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  END OF IMPACTION HANDLE SHEARED OFF DURING IMPACTION - IMPACTED THE CUP AND WHEN THE ARM WAS TAKEN AWAY FROM THE PATIENT AND THE IMPACTION PLATFORM TAKEN OFF THE IMPACTION HANDLE, PART OF THE IMPACTION HANDLE HAD BEEN SHEARED OFF AND FELL OUT OF THE IMPACTION PLATFORM ONTO THE STERILE BACK TABLE. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8211778 ↗
• MalfunctionDec 26, 2018Difficult to Remove; Non Reproducible Results; Difficult to Remove; Non Reproducible Results

  THA EVENT DESCRIPTION: WHEN IMPACTING THE CUP IT WAS CROSS-THREADED AND IT WAS DIFFICULT TO UNSCREW THE CUP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8196828 ↗
• MalfunctionDec 5, 2018Break; Non Reproducible Results; Break; Non Reproducible Results

  DURING IMPACTION, SHAFT AND PLATFORM BOTH BROKE. SURGICAL DELAY: 15 MINUTES. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8135094 ↗

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.