R3 ACETABULAR 71331854Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010597601), received between Nov 5, 2018 and May 2, 2023 — classified as 4 injuries, 1 malfunction.

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

• MalfunctionMay 2, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE ADHESIVE ON THE INNER PACKAGING OF A R3 0 HOLE ACET SHELL 54MM WAS NOTICED TO BE COMPROMISED/BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16854443 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BILATERAL PATIENT. IT WAS REPORTED THAT A SECOND REVISION SURGERY WAS PERFORMED THE PATIENT LEFT HIP ON (B)(6) 2018. THE REVISION SURGERY WAS PERFORMED DUE TO METALOSIS. THE CUP, HEAD, LINER AND SLEEVE WERE REMOVED, ONLY THE STEM WAS LEFT INSIDE THE PATIENT. DEPUY PARTS WERE IMPLANTED. ALTHOUGH THE PATIENT IS A BILATERAL ONE AND ELEVATED ION LEVELS (METALOSIS) WAS REPORTED THE RIGHT HIP CONSTRUCT CONSIST OF CERAMIC PARTS, THEREFORE THERE IS NO CONTRIBUTION OF THE RIGHT HIP CONSTRUCT TO THE ELEVATED ION LEVELS THAT PROVOKE THE SECOND REVISION SURGERY. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 11616780 ↗
• InjurySep 25, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED TO REMOVE THE ACETABULAR CUP DUE TO SEPTIC LOOSENING. HEAD AND LINER WERE ALSO REVISED.

  Patient problems: Injury

  MAUDE report 9120617 ↗
• InjuryJan 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD PERSISTENT PAIN AFTER REVISION SURGERY AND AN INJECTION INTRO THE TROCHANTERIC BURSA WAS GIVEN TO RELIEF THE PAIN. ALSO, XRAYS WERE DONE TO DIAGNOSE THE REASON OF THE PAIN BUT NOTHING ABNORMAL WAS FOUND.

  Patient problems: Pain

  MAUDE report 8209969 ↗
• InjuryNov 5, 2018High Test Results; High Test Results

  IT WAS REPORTED THAT PATIENT PRESENTS INCREASED TITANIUM LEVEL DUE TO TITANIUM IS PRESENT IN IMPLANTED COMPONENTS . TITANIUM LEVEL 3.64 (UPPER REFERENCE RANGE PER ALS (B)(4) AB IS 2.96).

  Patient problems: Patch Test, Abnormal Results Of; Test Result

  MAUDE report 8039630 ↗