R3 ACETABULAR 71335550Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 03596010598233), received between Dec 20, 2017 and Apr 20, 2026 — classified as 24 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA PERFORMED ON (B)(6) 2026, THE PATIENT EXPERIENCED INSTABILITY OF THE JOINT. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2026, IN WHICH A SYN POR HO FEM COM SZ 13, AN R3 3 HOLE ACET SHELL 50MM, AN REF SPHER HEAD SCREW 25MM, AN OR3O DUAL MOBILITY LINER 38/50, AN OR3O DUAL MOBILITY XLPE INSERT 28/38 AND AN OXINIUM FEM HD 12/14 28MM +0 WERE REPLACED. THE PATIENT LEFT SURGERY IN GOOD HEALTH. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Laxity

  MAUDE report 24924219 ↗
• InjuryJul 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER UNDERGOING A THR ON (B)(6) 2023, PATIENT EXPERIENCED THAT WHEN BENDING OVER, THE HIP LOCKS AND IT TAKES A WHILE TO GET IT UNLOCKED. PATIENT EXPRESSED THIS IS VERY PAINFUL UNTIL IT UNLOCKS. IN ADDITION, SURGEON AND HIS COLLEAGUE THINK MAYBE A NEW CUP OR CUT THE TENDON MAY BE REQUIRED. PATIENT EXPRESSED THAT SHE CANNOT GARDENING AND IS CAREFUL WHEN DOING THINGS IN THE HOUSE. IT IS UNKNOWN HOW THIS ADVERSE EVENT HAS BEEN ADDRESSED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint locking; Pain

  MAUDE report 22491265 ↗
• InjuryJan 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER UNDERGOING A THR ON (B)(6) 2023, PATIENT EXPERIENCED ASEPTIC LOOSENING CUP. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2024, DURING WHICH, THE R3 3 HOLE ACET SHELL 50MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Aseptic loosening

  MAUDE report 21068808 ↗
• InjuryNov 7, 2024Adverse 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) 2023, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 WHERE A R3 3 HOLE ACET SHELL 50MM, R3 20 DEG XLPE ACET LNR 36MM X 50MM AND COCR 12/14 FEM HEAD 36MM -3 WERE EXPLANTED. SURGEON CONVERTED PATIENT TO A DUAL MOBILITY, UTILIZING ANOTHER VENDOR'S IMPLANT AND A SMITH AND NEPHEW 28MM FEMORAL HEAD. PATIENT LEFT SURGERY IN GOOD HEALTH.

  Patient problems: Insufficient Information

  MAUDE report 20630476 ↗
• InjuryOct 25, 2024Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED AN ASEPTIC LOOSENING OF THE ACETABULAR CUP AND HIP PAIN. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2024. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Arthralgia; Inadequate Osseointegration

  MAUDE report 20539978 ↗
• InjuryOct 15, 2024Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED AN ASEPTIC LOOSENING OF THE R3 3 HOLE ACET SHELL 50MM. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A R3 3 HOLE ACET SHELL 50MM, A R3 +4MM XLPE LINER 36MM ID X 50MM OD AND A REF SPHER HEAD SCREW 30MM WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20450709 ↗
• InjuryNov 13, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A PLAINTIFF UNDERWENT A RIGHT THA SURGERY ON (B)(6) 2009, DUE TO DEGENERATIVE OSTEOARTHRITIS, THEY DEVELOPED HIP PAIN THAT THREATENED MOBILITY AND HAD ELEVATED COBALT LEVELS IN SERUM. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021, IN WHICH BLACKISH FLUID AND TRUNNIONOSIS WAS FOUND. ALL ACETABULAR AND FEMORAL HEAD COMPONENTS WERE EXCHANGED FOR A REDAPT SHELL AND OXINIUM S+N IMPLANTS. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Metal Related Pathology

  MAUDE report 18119611 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON (B)(6) 2020 TO ADDRESS JOINT SPACE NARROWING AND OSTEOPHYTE FORMATION CONSISTENT WITH END-STAGE ARTHRITIS, THE PATIENT REQUIRED AN IRRIGATION AND DEBRIDEMENT ON (B)(6) 2020 DUE TO A MSSA INFECTION. AFTER THIS PROCEDURE, A PICC LINE WAS INSERTED AND REMOVED 6 WEEKS LATER. THE PATIENT WAS ALSO PRESCRIBED WITH DURICEF AND DISCONTINUED 5 MONTHS AFTER INDEX SURGERY. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 16246720 ↗
• InjuryOct 31, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING A THR, A R3 3 HOLE ACET SHELL 50MM WOULD NOT SEAT WITH DESIGNED FIXATION, REAMED UP TO 52 AND WAS FIXATED. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705293 ↗
• InjuryOct 25, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING A THR, A R3 3 HOLE ACET SHELL 50MM WOULD NOT SEAT SO REAMED UP AND PUT IN A 52 MM CUP. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. SURGERY WAS COMPLETED WITH A NON-SIGNIFICANT DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15665686 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER PRIMARY LEFT HIP SURGERY WAS PERFORMED ON (B)(6) 2011, THE PATIENT EXPERIENCED ELEVATED METAL ION LEVELS, PAIN, MOBILITY PROBLEMS AND AN UNSPECIFIED PROBLEM IN THE ACETABULAR SHELL. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2021. DURING THE REVISION SURGERY, THE PATIENT¿S SHELL, METALLIC LINER, METALLIC FEMORAL HEAD, AND MODULAR HEAD SLEEVE WERE EXPLANTED AND ONLY THE STEM WAS LEFT IN PLACE. THE HIP WAS REPLACED WITH A DIFFERENT THA SYSTEM. THE OUTCOME OF THE PATIENT AFTER THE REVISION WAS GOOD.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 14455418 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING PRIMARY LEFT THR, THE PATIENT EXPERIENCED AN UNSPECIFIED INTRAOPERATIVE FRACTURE. THE PATIENT NEEDED A SUBSEQUENT FIXATION. THE LOCATION OF THE FRACTURE WAS NOT REPORTED. THE OUTCOME OF THE PLAINTIFF AFTER THE PRIMARY SURGERY IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 14455377 ↗
• InjuryFeb 28, 2022Adverse 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) 2021, REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 DUE TO ACCUMULATING WATER. THE R3 3 HOLE ACET SHELL 50MM WAS EXPLANTED. THE SURGEON SAYS IT WAS NOT CAUSED BY INFECTION. NO CAUSATIVE MICROORGANISM (BACTERIA) IS DETECTED. ALSO, THE SURGEON DID NOT THINK S+N DEVICES WERE DEFECTIVE. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF THE PATIENT.

  Patient problems: Swelling/ Edema

  MAUDE report 13619530 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR PATIENT EXPERIENCED RIGHT HIP IRRITATION AND TENDONITIS. THIS ADVERSE EVENT WAS TREATED WITH MEDICATION. THE PATIENT'S OUTCOME REMAINS UNKNOWN.

  Patient problems: Inflammation; Skin Inflammation/ Irritation

  MAUDE report 12154862 ↗
• InjuryJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON (B)(6) 2021, THE CLINICAL SUBJECT EXPERIENCED DISLOCATION ON THE RIGHT HIP THREE TIMES: ON THE DAY OF DISCHARGE ((B)(6) 2015) BY GETTING OUT OF THE SOFA, ON (B)(6) 2021 WHEN TURNING AROUND AND ON (B)(6) 2021 WHILE STANDING (THE LAST TWO WERE DESCRIBED AS A CONSEQUENCE OF FIRST DISLOCATION). EVERY TIME, THE ADVERSE EVENT WAS ADDRESSED VIA HOSPITALIZATION AND CLOSED REPOSITION ON THE SAME DATES THE DISLOCATIONS OCCURRED. THE ISSUE IS RESOLVED.

  Patient problems: Joint Dislocation

  MAUDE report 12028780 ↗
• InjuryMay 31, 2021Biocompatibility; Biocompatibility

  *US LEGAL MDL* IT WAS REPORTED THAT, AFTER A THA METAL-ON-METAL CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF´S LEFT HIP ON (B)(6) 2010, THE PLAINTIFF EXPERIENCED METALLOSIS CONSISTENT WITH FAILED METAL ON METAL HIP COMPONENTS. DUE TO SEVERE METALLOSIS, THE PLAINTIFF ALSO HAD A TROCHANTERIC FRACTURE. A REVISION SURGERY WAS PERFORMED ON (B)(6)2020 TO TREAT THIS ADVERSE EVENT. THE PLAINTIFF OUTCOME IS UNKNOWN.

  Patient problems: Bone Fracture(s); Metal Related Pathology

  MAUDE report 11907598 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  *US LEGAL* IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT¿S RIGHT HIP ON (B)(6) 2020 DUE TO ELEVATED ION LEVELS AND METALLOSIS. THE CUP, LINER AND HEAD WERE REMOVED AND EXCHANGED WITH COMPETITOR DEVICES. THE STEM REMAINED IMPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Metal Related Pathology; Nerve Damage; Osteolysis; Synovitis

  MAUDE report 11593556 ↗
• MalfunctionOct 13, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING SURGERY, IT WAS DIFFICULT TO LOCK THE R3 20 DEG XLPE ACETABULAR LINER 32MM X 50MM INTO THE R3 3 HOLE ACETABULAR SHELL 50MM. THE SHELL WAS COMBINED WITH 3 SCREWS AND HOLE COVER. FINALLY THE LINER COULD BE SET INTO THE SHELL BY HAMMERING REPEATEDLY, BUT IT CAUSED 30 MINUTES DELAY OF SURGERY. THE DOCTOR WANTS TO KNOW WHY THIS ISSUE WAS HAPPENED AND WHETHER THERE WERE ANY MANUFACTURAL DEVIATION. THERE WAS NO INJURY TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10670783 ↗
• InjuryMay 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR HAD BEEN PERFORMED, THE PATIENT HAD AN INTRA-ARTICULAR INFECTION. A REVISION SURGERY WAS PERFORM TO TREAT THIS ADVERSE EVENT. THE R3 THREE HOLE ACETABULAR CUP AND TWO SCREWS WERE EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 10054644 ↗
• InjuryJan 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. CUP WAS EXPLANTED.

  Patient problems: Injury

  MAUDE report 9557587 ↗
• MalfunctionNov 13, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY THE OUTER CUP WAS IMPLANTED AND THE LINER CANNOT BE LOCKED. ANOTHER CUP AND LINER WERE USED TO COMPLETE THE SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9318697 ↗
• InjuryMar 13, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT UPON REVIEWING POST OP XRAYS IMMEDIATELY FOLLOWING CLOSURE ON A PRIMARY HIP REPLACEMENT, IT WAS FOUND THAT ONE (POSSIBLY BOTH) SCREWS IMPLANTED DURING THE CASE ARE DISASSOCIATED WITH THE R3 CUP. TWO SCREWS WERE PUT IN RESPECTIVELY. EACH LOOK TO BE INTACT FROM THE POST OP X-RAY. THIS SUGGESTS THAT THE SCREWS WENT THROUGH THE R3 CUP. NEITHER THE FELLOW OR ATTENDING OPERATING APPLIED ABNORMAL AMOUNTS OF FORCE WHEN IMPLANTING THE SCREWS.

  Patient problems: Injury

  MAUDE report 8417175 ↗
• InjuryDec 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD AN MRI PERFORMED AND RECEIVED AN EPIDURAL STEROID SHOT DUE TO PAIN AND NUMBNESS IN KNEE. DOCTOR RELATES IT TO THE HIP PROSTHESIS.

  Patient problems: Pain

  MAUDE report 8167751 ↗
• InjuryMay 6, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A CUP DISLOCATION WHICH NEEDED TO BE REVISED.

  Patient problems: Injury

  MAUDE report 7489529 ↗
• InjuryMar 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A CORTISONE INJECTION WAS REQUIRED DUE TO RIGHT LATERAL HIP PAIN.

  Patient problems: Pain

  MAUDE report 7352715 ↗