R3 ACETABULAR 71331850Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010597588), received between Nov 25, 2018 and Feb 27, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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.

• InjuryFeb 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED BURSITIS. THIS ADVERSE EVENT WAS TREATED WITH A BURSAL INJECTION ON (B)(6) 2023, HOWEVER IT REMAINS ONGOING. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Inflammation

  MAUDE report 16444304 ↗
• InjuryJul 7, 2021Connection Problem; Physical Resistance/Sticking; Connection Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A THR, A R3 0 HOLE ACET SHELL 50 MM, CANNOT BE UNSCREWED AFTER IMPLANTING. IT IS UNKNOWN WHY THE SHELL WAS BEING REMOVED AND HOW THE PROCEDURE WAS FINISHED, ALTHOUGH IT WAS NOT SIGNIFICANTLY DELAYED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129472 ↗
• InjuryNov 10, 2020Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem; Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem

  IT WAS REPORTED THAT, DURING A THR, THE CUP WOULD NOT PROPERLY SEAT INTO ACETABULUM. SURGEON DECIDED TO USE A 3 HOLE CUP INSTEAD AND THAT ONE SEATED FINE. NO SURGICAL DELAY REPORTED. THE PATIENT WAS NOT INJURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10816286 ↗
• InjuryOct 15, 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 BECAUSE THE PATIENT HAD DISLOCATED SEVERAL TIMES WITH MOSTLY CLOSED REDUCTIONS DOING THE TRICK. AN OPEN REDUCTION WAS ALSO ATTEMPTED AS A LAST RESORT. ON OPENING THE WOUND, IT WAS VERY CLEAR THAT THE ACETABULAR COMPONENT WAS PROPERLY LOOSE CAUSING MUCH DISCOMFORT FOR THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Pain

  MAUDE report 10684960 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD STOMACH AND INTESTINAL PROBLEM, ASSESSED AS DEVICE RELATED (ONLY ONE FROM S+N), AND FURTHER DESCRIBED AS SUSPECTED TO BE DUE TO EXCESSIVE USE OF ANALGESICS AND IT WAS RESOLVED THROUGH GASTROSCOPY AND COLONOSCOPY.

  Patient problems: Injury

  MAUDE report 9556158 ↗
• InjuryJan 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTS ILIOPSOAS TENDINITIS ON OPERATIVE HIP. THIS WAS FOUND AFTER SURGERY. DEVICE BACK UP NOT APPLICABLE AND DELAY DURING PROCEDURE IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 8266478 ↗
• InjuryNov 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT EXPERIENCED INCREASED NICKEL LEVELS IN 2014 AS 2.39. IN (B)(6) 2018, IT WAS REPORTED A DECREASED NICKEL LEVEL BUT WERE STILL ABOVE UPPER LIMIT WITH VALUE OF 1.2.

  Patient problems: Injury

  MAUDE report 8100404 ↗