R3 ACETABULAR 71331856Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010597618), received between Sep 7, 2017 and Oct 15, 2025 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Connection 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A REVISION SURGERY PERFORMED ON (B)(6) 2019 DUE TO STEM SUSPECTED LOOSENING, THE PATIENT HAS EXPERIENCED PAIN PROBLEMS WHEN WALKING, SITTING, LAYING DOWN WHILE HAVING IMPLANTED THE R3 ACETABULAR SHELL. IT IS UNKNOWN HOW THE ISSUE IS BEING HANDLED.

  Patient problems: Pain

  MAUDE report 23302996 ↗
• MalfunctionNov 1, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A THR SURGERY, AFTER SEVERAL ATTEMPTS IT WAS NOT POSSIBLE INSERT A R3 0 DEG XLPE ACET LNR 32MM X 56MM AND A R3 0 DEG XLPE ACET LNR 36MM X MM56. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, REMOVING THE R3 0 HOLE ACET SHELL 56MM AND REPLACING IT WITH A R3 CUP WITH 3 HOLES, A NEW 56/32 INLAY COULD ONLY BE INSERTED WITH DIFFICULTY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12729734 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A RIGHT SIDE ACETABULAR FRACTURE.

  Patient problems: Bone Fracture(s); Hip Fracture

  MAUDE report 10662775 ↗
• MalfunctionSep 1, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING SURGERY, THE OUTER CUP COULD NOT BE IMPLANTED. ANOTHER CUP OF THE SAME SIZE, FROM SMITH AND NEPHEW, WAS USED TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF SURGERY WAS DELAYED. NO INJURY HAS BEEN REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10480668 ↗
• InjuryFeb 12, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO LUXATION OF THE CUP. EXPLANTED DEVICES: R3 CUP, R3 LINER AND COMPETITOR HEAD. IN ADDITION, THIS PATIENT UNDERWENT TWO CLOSED REDUCTIONS DUE TO PREVIOUS LUXATIONS ON (B)(6) 2011 AND (B)(6) 2011.

  Patient problems: Injury

  MAUDE report 9700497 ↗
• InjuryMay 22, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND INSTABILITY.

  Patient problems: Pain

  MAUDE report 8634425 ↗
• InjuryDec 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD INCREASED NICKEL, TITANIUM AND VANADIUM LEVELS. NO TREATMENT HAS BEEN GIVEN TO PATIENT.

  Patient problems: Injury

  MAUDE report 8123228 ↗
• InjurySep 27, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE PATIENT WAS COMPLAINING OF PAIN. A REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7915274 ↗
• InjurySep 7, 2017Connection Problem; Connection Problem

  IT WAS REPORTED THE LINER WOULD NOT LOCK INTO THE SHELL RESULTING IN A SURGICAL DELAY GREATER THAN 30 MINUTES.

  Patient problems: Injury

  MAUDE report 6849564 ↗