R3 ACETABULAR 71335556Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 03596010598264), received between Feb 12, 2018 and Jun 13, 2025 — classified as 26 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR SURGERY PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED A PERIPROSTHETIC INFECTION; THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, DURING WHICH ONE BIOLOX DELTA CE BALL HEAD 12/14 36L, ONE R3 36MM ID INTL DLT CER LNR 56MM, ONE R3 3 HOLE ACET SHELL 56MM, AND ONE POLARSTEM STEM STD TI/HA 4 NON-CEM WERE EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 22203956 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR SURGERY ON (B)(6) 2023, THE PATIENT EXPERIENCED PAIN. THIS ISSUE WAS ADDRESSED WITH PHYSIOTHERAPY AND MEDICATION THERAPY. THE PATIENT'S CURRENT HEALTH STATUS IS REPORTED AS RECOVERING.

  Patient problems: Pain

  MAUDE report 20736036 ↗
• InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A RIGHT PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2010, DURING WHICH A R3-THA SYSTEM WAS IMPLANTED. THE PATIENT EXPERIENCED CHRONIC PAIN, LIMITED RANGE OF MOTION AND LEG LENGTH DISCREPANCY. THEREFORE, A REVISION WAS PERFORMED ON (B)(6) 2023. DURING SURGERY IMPLANT LOOSENING, FEMORAL NECK STRESS REACTION DUE TO IMPINGEMENT, IMPINGEMENT LESION DUE TO CAPSULE PLACEMENT, AND ALSO SYNOVITIS AND OSTEOPHYTES WERE FOUND. THE SYSTEM WAS EXCHANGED FOR COMPETITOR IMPLANTS. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. NO OTHER COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Joint Impingement; Loss of Range of Motion; Pain; Synovitis; Unequal Limb Length

  MAUDE report 18669547 ↗
• InjuryOct 17, 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 AN UNDISCLOSED DATE, THE PATIENT EXPERIENCED LEFT HIP DISLOCATION. THIS ADVERSE EVENT WAS TREATED WITH MEDICATION AND SURGERY, HOWEVER THE PATIENT REMAINS RECOVERING. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 17950106 ↗
• InjuryDec 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR SURGERY PERFORMED ON (B)(6) 2014 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED AN UNSPECIFIED INFECTION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2015. DURING THIS PROCEDURE, THE MODULAR HEAD, ACETABULAR LINER AND ACETABULAR CUP WERE EXPLANTED. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY THR SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM STEM WITH AN R3 ACETABULAR CUP AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 16045557 ↗
• MalfunctionSep 9, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A THR PROCEDURE, THE R3 3 HOLE ACET SHELL 56MM DISASSOCIATED WITH INSERTION HANDLE UPON IMPACTION AND THEREFORE DID NOT INITIALLY GET IMPACTED IN THE PROPER POSITION. THEREFORE HAD TO REMOVE. REALIZED THE CENTRAL HOLE HAD CROSS THREADED. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392905 ↗
• InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UNDERGOING TOTAL HIP REPLACEMENT, THE PATIENT EXPERIENCED LEFT PUBIC RAMUS FRACTURE FOLLOWING A FALL. THIS ADVERSE EVENT WAS TREATED WITH PATIENT HOSPITALIZATION AND MEDICATION. THE OUTCOME HAS CURRENTLY BEEN POINTED AS RESOLVED. THE CONTRIBUTION OF THE IMPLANTED SMITH + NEPHEW DEVICES TO THIS EVENT CANNOT BE EXCLUDED AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 15280117 ↗
• InjuryMay 24, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER THR PROCEDURE HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DISLOCATION. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022 TO EXCHANGE THE R3 3 HOLE ACET SHELL 56MM, R3 CONST 56MM AND COCR 12/14 FEM HEAD 22 + 8. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 14485847 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2022 THE PATIENT EXPERIENCED DISLOCATION DUE TO THE COMPONENTS BEING PLACED IN A SUB-OPTIMAL POSITION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY TO EXPLANT THE COMPLETE SYSTEM ON (B)(6) 2022. THE PHYSICIAN REVISED AN R3 3 HOLE ACET SHELL 56MM. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 13591625 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ''(B)(6) LEGAL'': IT WAS REPORTED THAT AFTER A R3 THA CONSTRUCT WAS IMPLANTED ON (B)(6) 2008 THE PLAINTIFF EXPERIENCED ELEVATED METAL ION LEVELS ON BLOOD AND PSEUDOTUMOR. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO TREAT THESE ADVERSE EVENTS. DURING THE SURGERY, A HUGE AMOUNT OF BROWNISH-BLACK FLUID WAS FOUND ON THE HIP. ADDITIONALLY, GRAYISH-BLACK TISSUE IN A LARGE PORTION OF THE HIP WAS FOUND, AND A PSEUDOTUMOR WAS REMOVED AROUND THE ACETABULUM AND FEMORAL PORTION ON THE HIP. MICROSCOPY STUDY OF THE TISSUE REMOVED SHOWED TISSUE NECROSIS, FIBROSIS, CHRONIC INFLAMMATION, WITH A GOOD FOREIGN BODY HISTIOCYTE REACTION. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology; Nodule

  MAUDE report 12532643 ↗
• InjurySep 21, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT, AFTER A THR SURGERY, ONE SYN POR FEM COMP SZ 13, ONE R3 3 HOLE ACET SHELL 56MM, ONE OXINIUM FEM HD 12/14 36 MM -3, AND ONE R3 20 DEG XLPE ACET LNR 36MM X 56MM WERE ASSOCIATED WITH A POST-OPERATIVE REACTION (PAIN, INFECTION AND UNHEALED INCISION). THIS HAPPENED AFTER USE IN PATIENT. THE ISSUE WAS RESOLVED WITH A REVISION SURGERY, IN WHICH THE SURGEON REMOVED ALL THE IMPLANTS. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Impaired Healing; Pain; Unspecified Infection

  MAUDE report 12510298 ↗
• InjuryAug 4, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A THA SURGERY, AFTER IMPLANTING THE R3 3 HOLE ACET SHELL 56MM CUP, A REF INTERFIT THRD HOLE COVER CENTRAL SCREW WAS IMPLANTED, WHICH EVENTUALLY GOT BLOCKED AND ITS EXTRACTION WAS IMPOSSIBLE. SURGEON WAS FORCED TO REMOVE THE ALREADY IMPLANTED R3 3 HOLE ACET SHELL 56MM AND REPLACE IT WITH ANOTHER OF THE SAME SIZE; SURGEON DECIDES TO IMPLANT IT WITHOUT A CENTRAL SCREW. SURGERY WAS COMPLETED SUCCESSFULLY AFTER A NON SIGNIFICANT DELAY, WITHOUT ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12277413 ↗
• InjuryMay 18, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A THR PERFORMED ON (B)(6) 2014, THE PLAINTIFF EXPERIENCED HIGH FEVER AND ABNORMAL BLOOD LEVELS. A TWO-STAGE REVISION SURGERY WAS PERFORMED TO TREAT THESE ADVERSE EVENTS; ON (B)(6) 2020 THE DEVICES WERE EXPLANTED, AND A CEMENT SPACER WAS APPLIED, LEAVING THE PLAINTIFF WITH NO MOBILITY. THEN ON (B)(6) 2020 THE REVISION SURGERY WAS COMPLETED WITH THE IMPLANTATION OF NEW PROSTHESIS. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Fever; Loss of Range of Motion; Metal Related Pathology

  MAUDE report 11845347 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER PRIMARY THR, PATIENT PRESENTED A SORE BACK AND SCIATIC PAIN. X-RAYS SHOWED THAT R3 CUP MIGRATED SUPERIORLY AND HAD OPENED. A REVISION SURGERY WAS PERFORMED TO EXPLANT THE R3 3 HOLE ACETABULAR SHELL 56MM. STABILITY AND RANGE OF MOTION WAS REGAINED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 11326580 ↗
• InjuryJul 29, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT, WHO HAD UNDERGONE A THR IN SITU FROM 2011, RECENTLY FELL AT WORK AND WAS NON-WEIGHT BEARING SINCE. X-RAYS POST-FALL WERE INCONCLUSIVE, AND A PLAN WAS MADE TO REVISE THE HEAD, LINER, AND ALSO THE CUP IF REQUIRED. DURING REVISION SURGERY, IT WAS DETERMINED THAT THE STEM HAD A GOOD FIXATION BUT THE CUP WAS LOOSE. THE R3 3 HOLE ACETABULAR SHELL 56MM, R3 36MM ID US DELTA LINER 54MM OD, BIOLOX DELTA HEAD 36 MM 12/14 S / +0, AND 2 SCREWS WERE REVISED AND 56 MULTIHOLE CUP, 5 SCREWS, 56/36 CERAMIC LINER, 36+0 CERAMIC HEAD WERE IMPLANTED INSTEAD. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Fall; Inadequate Osseointegration

  MAUDE report 10338153 ↗
• InjuryNov 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A EMPERION STEM FRACTURE. INTRAOPERATIVELY IT WAS FOUND THAT THE PATIENT WAS INFECTED, ALL THE IMPLANTS WERE REMOVED AND REPLACED WITH COMPETITOR DEVICES.

  Patient problems: Unspecified Infection

  MAUDE report 9315171 ↗
• InjuryOct 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2012 PRIMARY LEFT HIP REPLACEMENT WAS PERFORMED AND IN (B)(6) 2017, PATIENT BEGAN HAVING WORSENING LEFT HIP PAIN. ON (B)(6) 2018, A REVISION SURGERY WAS PERFORMED DUE TO METALLOSIS AND PATIENT DISCOMFORT DUE TO A DISLOCATION THAT OCCURRED DAYS AFTER PRIMARY SURGERY, BLACK FLUID WAS ENCOUNTERED IN THE JOINT AND ALL DEVICES WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 9258500 ↗
• InjuryAug 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND BONE LOSS.

  Patient problems: Pain

  MAUDE report 8904430 ↗
• InjuryApr 3, 2019Fracture; Fracture

  IT WAS REPORTED THAT REVISION SURGERY WAS CARRIED OUT FOR A HIP PROSTHESIS EXCHANGE DUE TO IT BROKE AT THE SHAFT.

  Patient problems: Injury

  MAUDE report 8479030 ↗
• InjuryApr 3, 2019Fracture; Fracture

  IT WAS REPORTED THAT REVISION SURGERY WAS CARRIED OUT FOR A HIP PROSTHESIS EXCHANGE DUE TO IT BROKE AT THE SHAFT.

  Patient problems: Injury

  MAUDE report 8478654 ↗
• InjuryApr 1, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A POTENTIAL CUP LOOSENING IN RIGHT HIP.

  Patient problems: Injury

  MAUDE report 8470340 ↗
• InjuryJan 25, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DEVICE INSTABILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8279030 ↗
• InjuryJul 23, 2018Mechanical Problem; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THE SURGEON DOES NOT FAULT THE DEVICE. THE PRODUCT IS NOT AVAILABLE. NO MORE INFORMATION AVAILABLE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7712733 ↗
• InjuryJun 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A REVISION SURGERY PERFORMED DUE TO DEBILITATING RIGHT HIP PAIN AND INSTABILITY. ALSO, METALLOSIS AND REACTIVE INFLAMMATORY FLUID SURROUNDING THE HIP JOINT WERE DISCOVERED.

  Patient problems: Injury

  MAUDE report 7564044 ↗
• InjuryJun 3, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING AND DISLOCATION OF THE CUP.

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 7564039 ↗