R3 ACETABULAR 71335562Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010598295), received between Dec 2, 2018 and Nov 27, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER UNDERGOING A THR ON (B)(6) 2024, PATIENT EXPERIENCED INFECTION. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2024, DURING WHICH THE R3 3 HOLE ACET SHELL 62MM, THE R3 20 DEG XLPE ACET LNR 36MM X 62MM, THE BIOLOX DELTA CE BALL HEAD 12/14 36S AND THE POLARSTEM STEM STD TI/HA 8 NON CEM WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS FINE.

  Patient problems: Drug Resistant Bacterial Infection; Medical device site infection

  MAUDE report 20802998 ↗
• InjuryNov 9, 2021Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PRIMARY R3-THA METAL ON METAL CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF¿S RIGHT HIP ON (B)(6) 2009, THE PLAINTIFF EXPERIENCED A STAPHYLOCOCCUS SPP. INFECTION IN THE IMMEDIATE POSTOPERATIVE PERIOD. THE PLAINTIFF UNDERWENT A DEBRIDEMENT PROCEDURE AND THE INFECTION WAS RESOLVED UNEVENTFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12778640 ↗
• InjuryOct 20, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A THR PROCEDURE THE REAMER HANDLE WAS NOT REAMING CORRECTLY. SURGEON THOUGHT THAT THIS CAUSED THE CUP TO NOT SIT PROPERLY. NO INJURIES OR SURGICAL DELAYS REPORTED. SURGERY WAS FINISHED WITH THE SAME DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10708950 ↗
• InjuryDec 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO COXOARTHROSYS. THE R3 SHELL WAS EXPLANTED.

  Patient problems: Injury

  MAUDE report 8123241 ↗