RHS - RADIAL PROSTHESIS DTJ302Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03700386927041), received between Oct 7, 2022 and Aug 7, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ELBOW JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON A PATIENT REQUIRED REVISION SURGERY DUE TO STIFF ELBOW, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Loss of Range of Motion

  MAUDE report 22738052 ↗
• InjuryOct 16, 2024Osseointegration Problem; Osseointegration Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER ELBOW SYSTEM.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 JUNE 2018 ¿ JULY 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2019 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20460582 ↗
• InjuryOct 15, 2024Osseointegration Problem; Osseointegration Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER ELBOW SYSTEM.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 TO (B)(6) 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2018 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20449250 ↗
• InjuryOct 15, 2024Osseointegration Problem; Osseointegration Problem

  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 JUNE 2018 ¿ JULY 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2022 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20449213 ↗
• InjurySep 4, 2024Break; Fracture; Device Dislodged or Dislocated; Break; Fracture; Device Dislodged or Dislocated

  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 APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2023 A PATIENT REQUIRED REVISION SURGERY DUE TO BREAKAGE/DISSOCIATION OF THE PROSTHESIS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Dislocation

  MAUDE report 20136603 ↗
• InjuryOct 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RHS RADIO HEAD IMPLANT WAS IMPLANTED. THE PATIENT WAS FINE AFTER 3 MONTHS WORTH OF CHECK UPS BUT CAME BACK WITH ELBOW PAIN. THE X-RAY SHOWED THAT THE HEAD OF THE RADIO HEAD HAD POP OFF THE IMPLANT AND WAS LATERAL. THERE WAS A REVISION SURGERY PERFORMED.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 15562763 ↗