R3 ACETABULAR 71331852Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010597595), received between Feb 20, 2018 and Mar 22, 2021 — classified as 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MEDICAL INDICATED REVISION SURGERY ON THE RIGHT HIP ON (B)(6) 2018. THE REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THE SHELL, HEAD AND LINER WERE EXPLANTED AND REPLACED WITH ZIMMER PARTS. THE INDEX COMPETITOR STEM REMAINS IMPLANTED. THE PATIENT UNDERWENT A POSTERIOR SEPSIS AND PNEUMONIA AFTER THIS REVISION SURGERY, BUT NO S&N IMPLANTS WERE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Ambulation or Postural Difficulties; Chest Pain; Joint Dislocation

  MAUDE report 11541080 ↗
• InjuryJan 9, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING SURGERY CUP WOULD NOT SEAT. A BIGGER SIZE CUP HAD TO USE (S+N BACK UP). DELAY UNDER 30 MIN, AND NO INJURY TO PATIENT.

  Patient problems: Injury

  MAUDE report 9572220 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MRI DEMONSTRATED MILD DIFFUSE FATTY INFILTRATION. RIGHT HIP ASPIRATION WAS PERFORMED.

  Patient problems: Aspiration/Inhalation

  MAUDE report 9409351 ↗
• InjuryApr 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A POSTOPERATIVE INFECTION HAS OCCURRED IN THE PATIENT WHO RECEIVED THESE IMPLANTS. THE SURGEON INFORMED THE SALES REP ABOUT THIS.

  Patient problems: Unspecified Infection

  MAUDE report 8507262 ↗
• InjuryNov 15, 2018Break; Break

  IT WAS REPORTED THAT PART BROKE INSIDE THE PATIENT AND NEEDED TO BE REMOVED.

  Patient problems: Injury

  MAUDE report 8076576 ↗
• MalfunctionSep 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS PERFORMED ON (B)(6) 2010 DUE TO SWELLING. RIGHT HIP BURSA WAS INJECTED.

  Patient problems: Injury

  MAUDE report 7879186 ↗
• InjurySep 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2011 A MEDICAL INTERVENTION WAS PERFORMED DUE TO PAIN. A STEROID INJECTION WAS PERFORMED TO TREAT SEVERE PAIN THE PATIENT WAS PRESENTING.

  Patient problems: Injury

  MAUDE report 7879164 ↗
• InjuryFeb 20, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SECOND REVISION SURGERY DUE TO A MECHANICAL LOOSENING OF LEFT INTERNAL HIP PROSTHESIS.

  Patient problems: Injury

  MAUDE report 7284273 ↗