R3 ACETABULAR 71331858Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010597625), received between Aug 7, 2017 and Nov 29, 2023 — classified as 4 injuries, 1 malfunction.

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

• InjuryNov 29, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, A LEFT PRIMARY THA SURGERY WAS PERFORMED ON (B)(6) 2012, USING R3 ACETABULAR COMPONENTS, AN OXINIUM FEMORAL HEAD, WITH A MODULAR NECK AND SMF STEM. THE PATIENT THEN EXPERIENCED PROGRESSIVE HIP PAIN, ON (B)(6) 2019 WAS DIAGNOSED WITH HIGH COBALT LEVELS AND ON (B)(6) 2019 AN MRI SHOWED OSTEOLYSIS INVOLVING THE LEFT SUPERIOR LATERAL ACETABULUM. THEREFORE, ON (B)(6) 2022 A REVISION SURGERY WAS PERFORMED DUE TO METALLOSIS. DURING PROCEDURE DARK STAINED FLUID AND METALLOSIS OF SOFT TISSUES WAS FOUND WITH NO PERMANENT DAMAGE. AN OR3O DUAL MOBILITY LINER WAS IMPLANTED WITH A DEPUY FEMORAL HEAD AND STEM; SINCE THE REMOVAL OF THE SMF STEM WAS DIFFICULT, A DEPUY TROCHANTERIC PLATE AND WIRES WERE ALSO IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Metal Related Pathology; Osteolysis; Pain

  MAUDE report 18234450 ↗
• MalfunctionDec 10, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT IT WAS NOTICED WHEN OPENING THE BOX WITH R3 SHELL THE HCP DISCOVERED A HAIR STRAND ON THE INSIDE OF THE COVER ON THE INNER-BOX WITH THE IMPLANT. THE DELIVERY PROCESS TO STERILE FIELD WAS STOPPED AND ANOTHER BOX WITH SAME IMPLANT WAS OPENED AND IMPLANTED IN THE PATIENT. NO INJURY TO THE PATIENT. NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10987256 ↗
• InjuryDec 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS RE ADMITTED ON THE HOSPITAL DUE TO PAIN, HE WAS TREATED WITH MEDICATION.

  Patient problems: Pain

  MAUDE report 9530812 ↗
• InjuryDec 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS RE ADMITTED ON THE HOSPITAL DUE TO PAIN, HE WAS TREATED WITH MEDICATION.

  Patient problems: Pain

  MAUDE report 9530774 ↗
• InjuryAug 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT PRESENTED WITH LEFT HIP ARTHROPLASTY INFECTION. THE PATIENT UNDERWENT A LEFT HIP ARTHROTOMY FOR REMOVAL OF PROSTHESIS AND INSERTION OF CEMENT SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 6770013 ↗