R3 71365252Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010599544), received between Aug 12, 2019 and Jan 5, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Crack; Fracture; Difficult to Insert

  IT WAS REPORTED THAT DURING A THA SURGERY, THE TABS ON A R3 0DEG 36MM TRIAL 52MM WERE BROKEN OFF AND CRACKED. THE DEVICE WAS IDENTIFIED AS BROKEN WHEN IT DIDN'T SEAT IN THE CUP. THE SURGEON TRIED TO INSERT IT, AND THE TRIAL WOULDN'T SEAT. THE PROCEDURE WAS PERFORMED, 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 23956951 ↗
• MalfunctionFeb 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, IT WAS NOTICED THAT THE R3 0DEG 36MM TRIAL 52MM HAD SOME BROKEN PIECES. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743127 ↗
• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED THAT, THE R3 0DEG 36MM TRIAL 52MM LOCKING TAB BROKE. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: Insufficient Information

  MAUDE report 13725531 ↗
• InjuryJan 6, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, A R3 0 DEGREE 36MM INNER DIAMETER TRIAL ACETABULAR LINER 52MM OUTER DIAMETER WAS INSERTED, AND WHEN IT WAS REMOVED, THE SURGEON SAW A PIECE OF GREEN PLASTIC THAT BROKE OFF FROM IT. THE PIECE WAS RETRIEVED WITH EASE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13180970 ↗
• MalfunctionOct 11, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR, AN R3 0 DEGREE 36MM INNER DIAMETER TRIAL ACETABULAR LINER 52MM OUTER DIAMETER BROKE, NO PIECES FELL INSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12606293 ↗
• MalfunctionNov 17, 2020Break; Break

  IT WAS REPORTED THAT DURING SERVICE/PM THE R3 0DEG 36MM TRIAL 52MM WAS FOUND TO BE BROKEN AND CHIPPED. NO DELAY AND NO BACK UP APPLICABLE FOR THIS EVENT. NO INJURIES OR OTHER COMPLICATIONS WERE REPORTED AT THIS TIME.

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

  MAUDE report 10849926 ↗
• MalfunctionAug 12, 2019Break; Break

  IT WAS REPORTED THAT THE TRIAL BROKE WHILE REMOVING IT. ALL PIECES WERE RETRIEVED FROM INSIDE THE INCISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8882999 ↗