R3 71365254Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010599551), received between Dec 27, 2018 and Jan 30, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16, 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.

• MalfunctionJan 30, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE PLASTIC OF ONE (1) R3 0DEG 36MM TRIAL 54MM BROKE WHILE BEING REMOVED. ONE PIECE WAS REMOVED AND NOTHING WAS LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221301 ↗
• MalfunctionJun 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) R3 0DEG 36MM TRIAL 54MM BROKE. NO FRAGMENTS FELL IN THE PATIENT'S WOUND. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346698 ↗
• MalfunctionSep 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THR SURGERY, WHILE ATTEMPTED TO TAKE LINE OUT AFTER TRAILING WITH ONE (X1) R3 0DEG 36MM TRIAL 54MM THE SIDE PIECE BROKE OFF. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH & NEPHEW BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17675072 ↗
• MalfunctionMay 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A R3 0DEG 36MM TRIAL 54MM BROKE WHILE BEING REMOVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16943191 ↗
• MalfunctionAug 24, 2022Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, THE R3 0DEG 36MM TRIAL 54MM BROKE WHILE TRIALING. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING AN S+N BACKUP DEVICE. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15288534 ↗
• MalfunctionFeb 10, 2022Crack; Crack

  IT WAS REPORTED THAT, AFTER A THR SURGERY, IT WAS NOTICED THAT THE R3 0DEG 36MM TRIAL 54MM WAS CRACKED. AS THIS HAPPENED AFTER THE PROCEDURE, WAS NOT LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13506088 ↗
• MalfunctionJan 13, 2022Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, A R3 0DEG 36MM TRIAL 54MM BROKE. NO PIECES FELL INTO PATIENT. DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252595 ↗
• InjuryMay 21, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR, ONE OF THE TABS OF THE R3 0 DEGREES 36MM TRIAL 54MM BROKE OFF INSIDE THE PATIENT, UPON REMOVAL FROM THE CUP. SURGERY WAS RESUMED, WITHOUT ANY SIGNIFICANT DELAY, WITH THE SAME DEVICE; THEREFORE, PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11864551 ↗
• MalfunctionDec 28, 2020Break; Break

  IT WAS REPORTED AFTER THR PROCEDURE THE R3 0DEG 36MM TRIAL 54MM WAS FOUND TO BE BROKEN. NO DELAY OR BACK UP APPLICABLE FOR THIS EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077622 ↗
• MalfunctionNov 11, 2020Break; Break

  IT WAS REPORTED THAT DURING INSPECTION THE LINER WAS FOUND CHIPPED AND BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10826062 ↗
• MalfunctionDec 27, 2018Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE WAS DAMAGED. BROKE DURING USE, ALL PIECES ACCOUNTED FOR. NO DELAY OR INJURY REPORTED. PROCEDURE FINISHED WITH SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8200752 ↗