RHS - RADIAL PROSTHESIS DTJ304Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03700386927065), received between Apr 4, 2018 and Nov 8, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Disassembly” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2024Unstable; Unstable

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2012 AND (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2019 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 20640117 ↗
• InjuryOct 15, 2024Unstable; Unstable

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER ELBOW SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2018 ¿ (B)(6) 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6), 2020 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 20449254 ↗
• InjuryDec 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION. THE PATIENT WAS INITIALLY DOING WELL POST-OPERATIVELY AND DENIES ANY INJURY OR TRAUMA. THE PATIENT PRESENTED TO A ROUTINE FOLLOW UP VISIT AND WAS NOTED TO HAVE COMPLETE DISSOCIATION OF THE HEAD FROM THE STEM. AT THE TIME THE PATIENT WAS NOTICING SOME MECHANICAL SYMPTOMS, BUT DENIES AN ACUTE EPISODE. WE DISCUSSED REVISION VS. REMOVAL AND THE PATIENT AND FAMILY ELECTED TO PROCEED WITH EXPLORATION AND REVISION. REVISION SURGERY WAS PERFORMED. AT THE TIME OF SURGERY, THE STEM WAS WELL FIXED AND IN GOOD POSITION, WE PLACED A LARGER HEAD AND IT SNAPPED ONTO THE STEM APPROPRIATELY. THE PATIENT WAS INITIALLY DOING WELL, AGAIN WITH MULTIPLE FOLLOW UPS SHOWING STABLE PROSTHESIS, BUT THEN RETURNED TO THE OFFICE WHEN THEY FELT SOMETHING DIDN¿T FEEL RIGHT. THE PATIENT DENIES AN ACUTE EVENT OR INJURY. RADIOGRAPHS SHOWED THAT THE HEAD HAD ONCE AGAIN DISSOCIATED FROM THE STEM. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM WHERE THE ENTIRE PROSTHESIS WAS REMOVED AND THEY WAS LEFT WITH RADIAL HEAD EXCISION.

  Patient problems: Discomfort

  MAUDE report 16057443 ↗
• MalfunctionApr 4, 2018Disassembly; Disassembly

  WE WERE ADVISED A WEEK AFTER THE SURGERY THAT THE PATIENT HAD COME BACK BECAUSE THE RADIAL HEAD HAD DISASSOCIATED FROM THE STEM. THE SURGEON THINKS THE ISSUE IS NOT RELATED TO THE IMPLANT ITSELF AND SUSPECTS SOMETHING MAY HAVE HAPPENED BUT DON'T KNOW WHAT. SHE HAS INDICATED THE PATIENT IS NOT MENTALLY SOUND.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7395482 ↗
• MalfunctionApr 4, 2018Disassembly; Disassembly

  WE WERE ADVISED A WEEK AFTER THE SURGERY THAT THE PATIENT HAD COME BACK BECAUSE THE RADIAL HEAD HAD DISASSOCIATED FROM THE STEM. THE SURGEON THINKS THE ISSUE IS NOT RELATED TO THE IMPLANT ITSELF AND SUSPECTS SOMETHING MAY HAVE HAPPENED BUT DON'T KNOW WHAT. SHE HAS INDICATED THE PATIENT IS NOT MENTALLY SOUND.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7395479 ↗