R3 ACETABULAR 71335558Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010598271), received between Jun 22, 2018 and Sep 25, 2025 — classified as 13 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING A THR SURGERY, THE LINER AND CUP WERE FOUND TO BE INCOMPATIBLE. AFTER A DELAY OF MORE THAN 30 MINUTES, THE PROCEDURE WAS RESUMED USING A SIMILAR SMITH & NEPHEW DEVICE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23143958 ↗
• InjuryJun 11, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A PLAINTIFF UNDERWENT A RIGHT R3-THA PRIMARY SURGERY ON (B)(6) 2010, THEY LATER EXPERIENCED AND WERE DIAGNOSED WITH SEVERE PAIN, LIMITED MOBILITY, METALLOSIS, PSEUDOTUMOUR FORMATION, AND COLD WELDING OF THE SLEEVE ONTO THE FEMORAL STEM. THEREFORE, A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2023, DURING WHICH THE HIP WAS CONVERTED INTO A DUAL MOBILITY THA USING COMPETITOR DEVICES. THEY WERE TAKEN TO PACU IN STABLE CONDITION.

  Patient problems: Metal Related Pathology

  MAUDE report 19512526 ↗
• InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE SURGEON DETERMINED THAT THE CUP WAS "TOO ANTEVERTED". THE REVISION SURGERY WAS DONE ON (B)(6)2023, IN WHICH A DUAL MOBILITY OR3O LINER WAS USED FOR THE BEARING SURFACE AND THE ACETABULAR IMPLANTS WERE REVISED TO A REDAPT MOD CUP WITH LESS VERSION THAN WHAT WAS PREVIOUSLY IMPLANTED. NO DELAY WAS REPORTED AND THE PATIENT LEFT SURGERY IN GOOD HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17439608 ↗
• InjuryFeb 3, 2023Failure to Osseointegrate; Malposition of Device; Device Dislodged or Dislocated; Failure to Osseointegrate; Malposition of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, OVER THE COURSE OF TWO WEEKS FOLLOWING A RIGHT THA HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED PAIN AND DISCOMFORT BECAUSE THE PROSTHESIS LOOSENED AND MOVED. ON (B)(6) 2022, X-RAYS SHOWED THE FAILURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REPLACE THE FAILED PARTS, WHICH SET THE RECOVERY TIME BACK BY APPROXIMATELY THREE WEEKS. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Arthralgia; Discomfort; Failure of Implant; Joint Dislocation

  MAUDE report 16297600 ↗
• InjuryMay 26, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A SURGERY HAD BEEN PERFORMED ON THE (B)(6) 2010, THE PATIENT EXPERIENCED PAIN. A BONE SCAN SHOWED LOOSENING OF THE R3 3 HOLE ACET SHELL 58MM AND METAL IONS LEVEL RAISE. A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Infiltration into Tissue; Pain

  MAUDE report 14518335 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ''(B)(6) LEGAL'': IT WAS REPORTED THAT, AFTER AN R3-THA CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF¿S LEFT HIP ON (B)(6) 2012, THE PLAINTIFF EXPERIENCED METALLOSIS WITH THE PRESENCE OF AN ALVAL LESION, WEAKNESS, PAIN, SWELLING AND PSEUDOTUMOR FORMATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 TO TREAT THIS ADVERSE EVENT. THE 46MM DIAMETER BHR MODULAR HEAD, R3 ACETABULAR LINER CO-CR AND R3 58MM THREE HOLE HEMISPHERICAL STIKTITE SHELL WERE EXPLANTED. THE PLAINTIFF WAS TAKEN TO RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain; Swelling/ Edema; Tissue Breakdown

  MAUDE report 12519937 ↗
• InjuryJun 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2011, THE CLINICAL SUBJECT EXPERIENCED A DISLOCATION AND WAS RE-HOSPITALIZED ON (B)(6) 2021. THE ADVERSE EVENT WAS TREATED WITH A NON-INVASIVE PROCEDURE. THE PATIENT IS RECOVERED.

  Patient problems: Joint Dislocation

  MAUDE report 12053619 ↗
• MalfunctionJun 22, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT SHORTLY AFTER IMPLANTATION THE PATIENT BENT OVER AND FELT A POP. REVISION SURGERY WAS SUBSEQUENTLY PERFORMED IN EARLY 2019, DURING WHICH THE SURGEON NOTICED THAT THE LINER HAD BECOME DISENGAGED FROM THE R3 SHELL. ONLY THE LINER WAS REVISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038922 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THA A REVISION SURGERY WAS NECESSARY AND THE DEVICES IMPLANTED WERE REMOVED IN ORDER TO IMPLANT NEW ONES AT A DIFFERENT ANGLE. THE PATIENT WAS NOT INJURED.

  Patient problems: Failure of Implant

  MAUDE report 11722550 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SECOND REVISION SURGERY WAS PERFORMED ON THE PATIENTS RIGHT HIP ON (B)(6) 2019 DUE TO SUBSEQUENT INSTABILITY ON THE PATIENT RIGHT HIP. AMONG THE INTRAOPERATIVE FINDINGS THERE SOME AREAS OF DEVITALIZED OR NECROTIC TISSUE FROM PRE-EXISTING PSEUDOTUMOR. THE PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Joint Dislocation; Joint Laxity; Metal Related Pathology; Necrosis

  MAUDE report 11480068 ↗
• InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THE SECOND SURGERY DUE TO THE FRACTURE ON (B)(6) 2020 THE PATIENT GOT INFECTED THEREFORE IT WAS DONE A REVISION SURGERY ON (B)(6) 2021. ALL IMPLANTS WERE REMOVED. ( OXINIUM FEM HD 12/14 36 MM -3, REDAPT SLVLS MONO STEM 190MM SZ 19 SO, R3 3 HOLE ACET SHELL 58MM, R3 20 DEG XLPE ACET LNR 36MM X 58MM, TWO REF SPHER HEAD SCREW 20MM, THREE ACC 2.0MM COCR CABLE W/CLAMP.) THOSE IMPLANTS WERE REPLACED, EXCEPTED FOR THE FLEXIBLE OSTEOTOMES USED TO REMOVE THE REDAPT SLVLS MONO STEM 190MM SZ 19 SO AND ALSO WAS IMPLANTED FOUR CC 2.0MM COCR CABLE W/CLAMP. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Post Operative Wound Infection

  MAUDE report 11263320 ↗
• InjuryOct 8, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY, AFTER INSERTING THE ACETABULUM CUP 58MM, A 58MM POLY LINER COMPATIBLE WITH THE 58MM CUP WAS TRIED TO BE USED BUT COULD NOT BE INSERTED, A SECOND LINER WAS TRIED (58MM 20 DEGREE ELEVATION TYPE) BUT WOULD STILL NOT WORK AND A THIRD LINER WAS TRIED BUT THE SAME PROBLEM OCCURRED. FINALLY ADDITIONAL REAMING WAS PERFORMED AND A 60MM CUP WAS USED TO COMPLETE THE PROCEDURE. A DELAY GREATER DE 30 MINUTES OCCURRED WITHOUT SIGNIFICANT EFFECT ON THE PATIENT.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10649442 ↗
• InjuryMay 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED DUE TO PERIPROSTHETIC INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8643156 ↗
• InjuryMar 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT DUE TO DISLOCATION. NO ADDITIONAL DETAILS OF THE REVISION SURGERY REPORTED. THREE EXPLANTS REPORTED. NO DELAY OR ADDITIONAL INJURIES REPORTED. A BACK UP DEVICE WAS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8448976 ↗
• MalfunctionJan 29, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SURGERY, WHILE IMPLANTING A SCREW, SEVERAL METAL FILAMENTS APPEARED AND WERE REMOVED. SCREW WAS NOT REMOVED AND FIXED WITH A 20 SCREW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8284584 ↗
• InjuryJun 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A LEFT HIP REVISION SURGERY WAS PERFORMED DUE TO CONTINUED INSTABILITY. THE R3 SHELL AND THE HEAD WERE REMOVED.

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 7631236 ↗