R3 71365256Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010599568), received between Feb 19, 2019 and Mar 14, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 14, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR, ONE (1) R3 0DEG 36 MM TRIAL 56 MM BROKE. NO PIECES FELL INTO THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24600290 ↗
• MalfunctionJan 5, 2022Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, THE LOCKING TAB ON R3 0DEG 36MM TRIAL 56MM BROKE WHILE OUTSIDE THE PATIENT. NO PIECES FELL INTO PATIENT. NO PATIENT HARM. 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 13170862 ↗
• MalfunctionAug 9, 2021Break; Break

  IT WAS REPORTED THAT A R3 0DEG 36 MM TRIAL 56 MM IS BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12296826 ↗
• MalfunctionApr 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, THE R3 0DEG 36MM TRIAL 56MM IS ROUGH AROUND THE CENTER. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624874 ↗
• InjuryJul 14, 2020Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING THA SURGERY, THE PLASTIC TAB OF THE R3 0 DEGREES 36MM TRIAL 56MM BROKE OFF INTERNAL TO PATIENT. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE, WITH NO SURGICAL DELAY. THE BROKEN PIECE WAS RECOVERED AND THERE WAS NO INJURY TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10272579 ↗
• MalfunctionFeb 19, 2019Break; Break

  IT WAS REPORTED THAT DURING THR THE TABS IN THE OUTSIDE OF TRIAL BROKE OFF FROM USAGE. NO DELAY OR INJURY REPORTED. A BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8351499 ↗