R3 ACETABULAR 71335554Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 03596010598257), received between Apr 18, 2017 and Oct 28, 2024 — classified as 23 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2024Adverse 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) 2024, THE PATIENT EXPERIENCED INFECTION AND ALSO, HE DISLOCATED TWICE BEFORE FINDING THE INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION THR SURGERY ON (B)(6) 2024, IN WHICH ONE (1) R3 3 HOLE ACET SHELL 54MM, ONE (1) REF SPHER HEAD SCREW 30MM, ONE (1) OR3O DUAL MOBILITY LINER 42/54, ONE (1) OR3O DM XLPE INSERT 28/42, ONE (1) OXINIUM FEM HD 12/14 28MM -3 AND ONE (1) REDAPT SLVLS MONO STEM 240MM SZ 20 SO WERE EXPLANTED. PATIENT LEFT SURGERY IN GOOD HEALTH. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Dislocation; Medical device site infection

  MAUDE report 20544792 ↗
• InjuryOct 7, 2024Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT DURING A PRIMARY HIP PROSTHESIS, ONE (X1) R3 3 HOLE ACET SHELL 54MM, ONE (X1) R3 20 DEG XLPE ACET LNR 36MM X 54MM AND ONE (X1) R3 20 DEG XLPE ACET LNR 32MM X 54MM WERE NOT COMPATIBLE WITH THE SIZE IDENTIFIED ON THE PACKAGING, WHEN COMPARED TO THE CORRESPONDING MILLING TOOL USED FOR THEIR RESPECTIVE PREPARATION. THE SURGEON NEEDED TO MILL A LARGER SIZE THAN THE ONE HE HAD INITIALLY CHOSEN SO THAT HE COULD COMPLETE THE PROCEDURE WITHOUT RISK OR HARM TO THE PATIENT. IT IS UNKNOWN HOW SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY (LESS THAN OR EQUAL TO 30MINS). NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384994 ↗
• InjurySep 17, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER A THR SURGERY PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A DISLOCATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO EXCHANGE THE R3 CUP TO A POLAR DUAL MOBILITY. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 20238130 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR ON (B)(6) 2022, PATIENT BEGAN TO EXPERIENCE RIGHT HIP PAIN (ONSET 19-JAN-2022) AND WAS HOSPITALIZED UNTIL (B)(6) 2022, DUE TO UNMANAGED PAIN AND INABILITY TO AMBULATE. THE EVENT IS RESOLVING.

  Patient problems: Implant Pain

  MAUDE report 19767989 ↗
• InjuryMay 21, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER AN R3-THA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT HIP ON (B)(6) 2009, THE PATIENT EXPERIENCED METALLOSIS AND PAIN. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, ALL COMPONENTS WERE EXPLANTED AND REPLACED WITH A COMPETITORS¿ THA SYSTEM. INTRAOPERATIVELY, INFLAMMATORY SYNOVIAL CHANGES WERE NOTICED WITH A SMALL GROSS MACROSCOPIC AREA WITH TISSUE STAINING. THE TRUNNION SHOWED MILD SIGNS OF CORROSION. THE PATIENT WAS TRANSFERRED IN A STABLE CONDITION TO THE RECOVERY ROOM.

  Patient problems: Metal Related Pathology; Pain; Synovitis

  MAUDE report 14466695 ↗
• InjuryApr 25, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A PRIMARY HIP REPLACEMENT ON (B)(6) 2019, PATIENT SUFFERED A TRAUMATIC FALL WITH DISLOCATION AND SOFT TISSUE DAMAGE. PATIENT HAD TWO MORE DISLOCATIONS AFTERWARDS. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022 IN WHICH THE SUPPORTING MUSCLES WERE NOTED TORN AND NEEDED TO BE REPAIRED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 14192193 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  'US LEGAL" IT WAS REPORTED THAT THE PATIENT SUFFERED FROM A SURGICAL SITE INFECTION IN HER RIGHT HIP 12 DAYS AFTER A PRIMARY RIGHT HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2010. AS REPORTED, THE AREA OF INCISION LINE REDDENED AND WAS WARM TO TOUCH. SMALL AMOUNT OF CLEAR YELLOW DRAINAGE FROM INCISION WAS NOTICED. THE PATIENT WAS TREATED WITH ANTIBIOTIC THERAPY. THE ISSUE WAS RESOLVED, AND THE OUTCOME OF THE PATIENT WAS POSITIVE.

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 13483220 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  US LEGAL BILATERAL PATIENT. IT WAS REPORTED THAT AFTER A RIGHT HIP REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 DUE TO AN INFECTION, THE PATIENT KEPT SUFFERING FROM AN ONGOING INFECTION. ONE YEAR AFTER THE REVISION, THE PATIENT WAS STILL TAKING SUPPRESSIVE ANTIBIOTICS, AS PER INDICATION OF THE INFECTIOUS DISEASE DOCTOR. A NM BONE SCAN 3 PHASE WAS PERFORMED ON (B)(6) 2018 AND SUGGESTED THE PRESENCE OF SOFT TISSUE INFLAMMATION. ON (B)(6) 2019 THE PATIENT HAD AN ASPIRATION UNDER GENERAL ANESTHESIA AND APPROXIMATELY 7 CC OF SOMEWHAT CLOUDY JOINT FLUID WAS REMOVED FROM THE RIGHT HIP. IT IS UNKNOWN IF/HOW THE ISSUE WAS TREATED. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 13416727 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  US LEGAL- BILATERAL PATIENT. IT WAS REPORTED THAT AFTER THE PATIENT UNDERWENT A FIRST REVISION SURGERY OF THE LEFT HIP DUE TO TRUNNIONOSIS AND METALLOSIS ON (B)(6) 2019, THE PATIENT KEPT SUFFERING FROM COMPLICATIONS RELATED TO PROSTHETIC JOINT INFECTION. THE PATIENT HAD ISSUES WITH POSTOP WOUND HEALING AND DEVELOPED INFECTIONS, REQUIRING SURGICAL DEBRIDEMENT TWICE, AS WELL AS RECURRENT ASPIRATIONS. ON (B)(6) 2019, THE PATIENT HAD A SECOND REVISION SURGERY, WHERE THE ACETABULAR COMPONENT WAS REPLACED WITH ANTIBIOTIC SPACERS.

  Patient problems: Bacterial Infection

  MAUDE report 13416575 ↗
• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  US LEGAL. IT WAS REPORTED THAT AFTER A LEFT THA WAS PERFORMED ON (B)(6) 2016, PLAINTIFF EXPERIENCED INCREASING PAIN, EFFUSION ON LEFT HIP, AND HEMATOMA ON THE HIP. AN IRRIGATION AND DEBRIDEMENT OF HEMATOMA, AND DEBRIDEMENT OF LEFT TROCHANTERIC BURSA WAS PERFORMED ON (B)(6) 2019 TO INITIALLY TREAT THESE ADVERSE EVENTS. HOWEVER, PLAINTIFF CONTINUED HAVING ISSUES, INCLUDING HIGH COBALT LEVELS ON BLOOD ( (B)(6) 2019: COBALT 19 MCG/L). DUE TO THIS, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019. DURING SURGERY ALL THE S+N DEVICES WERE EXPLANTED, AND NEW DEVICES WERE IMPLANTED. AFTER THE REVISION SURGERY, THE PLAINTIFF EXPERIENCED MULTIPLE INTERVENTIONS INCLUDING A SECOND REVISION SURGERY AND OPEN REDUCTION WITH INTERNAL FIXATION OF LEFT PELVIS FRACTURE, HOWEVER SINCE THERE IS NO INFORMATION ABOUT THE MANUFACTURER FOR ALL DEVICES IMPLANTED ON THE FIRST REVISION SURGERY, DETERMINATION IF SOME OF THE DEVICES ARE FROM S+N CANNOT BE CONCLUDED. A CORRELATION BETWEEN THESE EVENTS AND OUR DEVICES CANNOT BE STABLISH. PLAINTIFF OUTCOME IS UNKNOWN.

  Patient problems: Bone Fracture(s); Hematoma; Infiltration into Tissue; Inflammation; Pain; Swelling/ Edema

  MAUDE report 12638914 ↗
• InjuryJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THA PERFORMED IN 2000 (SPECIFIC DATE IS UNKNOWN), THE PATIENT EXPERIENCED PAIN AND SQUEAKING SOUND IN THE ARTICULATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THESE ADVERSE EVENTS. THE BIOLOX FORTE CER 28 HD 12/14 +4 ((B)(4)), THE LINER ((B)(4)) AND THE R3 3 HOLE ACET SHELL 54MM ((B)(4)) WERE REMOVED DURING THE REVISION SURGERY. MORE DETAILS ABOUT THE SURGERY ARE UNKNOWN. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 12022908 ↗
• InjuryJun 1, 2021Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  IT WAS REPORTED THAT, DURING THR SURGERY, THE SCREW THREAD ON A R3 3 HOLE ACET SHELL 54MM SPLIT OFF FROM THE IMPACTOR THREAD WHILE INSERTING THE R3 3 HOLE ACET SHELL 54MM IN THE ACETABULUM. A SURGICAL DELAY OF LESS THAN 30 MINUTES OCCURRED DUE TO THIS EVENT. NEVERTHELESS, THE PROCEDURE WAS CONCLUDED WITH A SMITH AND NEPHEW BACKUP SHELL. NEITHER PATIENT INJURY NOR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11914201 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL RIGHT THA ON MAY 5, 2017 DUE TO A LABRAL TEAR, PLAINTIFF UNDERWENT RIGHT REVISION SURGERY ON MAY 16, 2017 DUE TO FEMORAL LOOSENING. FOLLOWING REVISION SURGERY, PLAINTIFF CONTINUES TO HAVE CHRONIC PAIN SYNDROME AND UNDERWENT A TROCHANTERIC INJECTION PROCEDURE ON MAY 31, 2018. NO MEDICAL RECORDS HAVE BEEN RECEIVED INDICATING A SECOND REVISION SURGERY OR ADDITIONAL INTERVENTIONS. PLAINTIFF CONTINUES WITH CHRONIC PAIN SYNDROME MANAGED WITH MEDICATION AND PHYSIOTHERAPY.

  Patient problems: Inflammation; Pain

  MAUDE report 11548661 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO BLACK CORROSION/ METALLOSIS ON THE FEMORAL NECK TAPER AND LINER TAPER.

  Patient problems: Metal Related Pathology

  MAUDE report 11376877 ↗
• InjuryNov 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN ASSOCIATED TO A POSSIBLE METAL RELATED PATHOLOGY. AN R3 THA SYSTEM WAS REVISED DURING THIS PROCEDURE.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 10882186 ↗
• InjuryAug 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A THR IN SITU FROM 2011, HAD A FALL RECENTLY AT WORK AND HAS BEEN 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. A REVISION SURGERY WAS PERFORMED AND STEM HAD GOOD FIXATION, BUT CUP WAS LOOSE. CUP, LINER, HEAD AND SCREWS WERE REVISED. RE-IMPLANTED WERE 56 MULTIHOLE CUP, 5 X SCREWS, 56/36 CERAMIC LINER, 36+0 CERAMIC HEAD.

  Patient problems: Injury

  MAUDE report 10359909 ↗
• InjuryJan 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A 2 STAGE REVISION DUE INFECTION. ALL THE COMPONENTS WERE REMOVED AND AN ANTIBIOTIC IMPREGNATED PROSTALAC SPACER WAS USED. THE PATIENT WAS RE IMPLANTED WITH A FULL SMITH AND NEPHEW SYSTEM ON (B)(6) 2012.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9634237 ↗
• InjuryMay 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON AN ACETABULUM. FURTHER INFORMATION IS UNKNOWN YET.

  Patient problems: Injury

  MAUDE report 8643494 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT RECURRENT DISLOCATIONS ON (B)(6) 2017 & (B)(6) 2018 OCCURRED.

  Patient problems: Joint Dislocation

  MAUDE report 8642581 ↗
• InjuryMar 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO CONSISTENT PAIN.

  Patient problems: Pain

  MAUDE report 8396905 ↗
• InjuryDec 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO RECURRENT DISLOCATIONS OF LEFT TOTAL HIP ARTHROPLASTY.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8194938 ↗
• InjuryNov 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON LEFT HIP DUE TO INFECTION. FEMORAL HEAD AND ACETABULAR CUP WERE REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED TO TREAT IT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8043874 ↗
• InjuryApr 18, 2017Detachment Of Device Component; Detachment Of Device Component

  REVISION SURGERY WAS PERFORMED BECAUSE THE PATIENT HAS HAD PAIN AND EVIDENCE OF CUP MIGRATION ACCORDING TO X-RAY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6500207 ↗