R3 ACETABULAR 71335548Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010598226), received between Apr 12, 2017 and Aug 1, 2025 — classified as 1 death, 13 injuries, 2 malfunctions.

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 18, 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.

• InjuryAug 1, 2025Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED AN ASEPTIC LOOSENING ACETABULAR CUP AND PAIN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) R3 3 HOLE ACET SHELL MM48, ONE (1) R3 0 DEG +4 XLPE ACET LNR 32MM X 48MM AND ONE (1) OXINIUM FEM HD 12/14 32MM +0 WERE EXPLANTED. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 22685083 ↗
• InjuryApr 30, 2025Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN ASEPTIC LOOSENING ACETABULAR CUP. THIS ADVERSE EVENT WAS SOLVED/TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) R3 0 DEG +4 XLPE ACET LNR 32MM X 48MM, ONE (1) OXINIUM FEM HD 12/14 32MM +0 AND ONE (1) R3 3 HOLE ACET SHELL MM48 WERE EXPLANTED. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 21934234 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THA, WAS PERFORMED ON (B)(6) 2011, THE PATIENT STARTED DEVELOPING RIGHT GROIN PAIN ON OR ABOUT (B)(6) 2024. TEST IMAGING ON (B)(6) 2024 SHOWED A STABLE RIGHT THA WITHOUT EVIDENCE OF PERIPROSTHETIC FRACTURE, LUCENCY, OR EVIDENCE OF SUBSIDENCE. BUT A QUESTIONABLE IRREGULARITY OF THE RIGHT INFERIOR PUBIC RAMUS, WHICH COULD REFLECT A NONDISPLACED FRACTURE VERSUS ARTIFACT WAS OBSERVED. THEY LATER EXPERIENCED A SPONTANEOUS PELVIC FRACTURE WITHOUT TRAUMA, ON OR ABOUT (B)(6) 2024. IT WAS MENTIONED THAT IT IS MORE LIKELY THAN NOT THAT PRIOR HIP SURGERIES AND ALTERED ANATOMY ARE A FACTOR IN THE STRESS RESPONSE CAUSING THIS FRACTURE. LATERALITY WAS NOT SPECIFIED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Arthralgia; Bone Fracture(s); Hip Fracture

  MAUDE report 20843197 ↗
• InjuryNov 20, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIMENTED AN ASEPTIC LOOSENING OF THE R3 3 HOLE ACET SHELL MM48. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, IN ORDER TO EXCHANGE THE CUP, THE FEMORAL HEAD AND THE LINER. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Aseptic loosening

  MAUDE report 20734876 ↗
• InjuryOct 8, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A THA SURGERY PERFORMED ON AN UNSPECIFIED DATE, THE R3 3 HOLE ACET SHELL MM48 HAD AN ASEPTIC LOOSENING. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, IN ORDER TO EXCHANGE THE IMPLANT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20397505 ↗
• DeathJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THR SURGERY WAS PERFORMED DUE TO OSTEOARTHRITIS ON (B)(6) 2022, IN WHICH A OXINIUM FEM HD 12/14 32MM -3, A POLARSTEM STEM LAT.TI/HA 4 NON-CEM, A R3 3 HOLE ACET SHELL MM48 AND A R3 0 DEG XLPE ACET LNR 32MM X 48MM WERE IMPLANTED, THE PATIENT DIED AROUND ON (B)(6) 2022. THE SPECIFIC DATE AND REASON OF THE PATIENT'S DEATH ARE UNKNOWN. THERE IS NO CURRENT EVIDENCE THAT SUGGESTS A RELATIONSHIP BETWEEN THE IMPLANTED DEVICES AND THE REPORTED DECEASE.

  Patient problems: Insufficient Information

  MAUDE report 17303107 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE PMCF TITLED DCA-1000 ACCORD SS CLINICAL DATASET, IT WAS REPORTED THAT, AFTER UNDERGOING RIGHT THA, ONE (1) PATIENT EXPERIENCED UNSPECIFIED EVENTS THAT LED TO A SUBSEQUENT INTERNAL FIXATION SURGERY. THIS SURGERY WAS PERFORMED ON 26-SEP-2022, IN WHICH AN INTRAOPERATIVE FRACTURE OCCURRED. AS REMEDIAL ACTION, AN ACCORD CABLE SYSTEM WAS IMPLANTED. PATIENT IS CURRENTLY UNDER OBSERVATION AND NEXT APPOINTMENT IS SCHEDULED FOR (B)(6) 2023.

  Patient problems: Hip Fracture

  MAUDE report 16583091 ↗
• MalfunctionJun 17, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TOTAL HIP ARTHROPLASTY USING A R3 3 HOLE ACET SHELL MM48 THE LINER FELL OFF AND DISLODGED. THE PROCEDURE WAS COMPLETED WITH A 50 MM ACETABULAR CUP BACK UP DEVICE; IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12018266 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE MONTH AND A HALF AFTER PRIMARY THR SURGERY, A PATIENT SUFFERED A DISLOCATION AND HAD TO UNDERWENT TO REVISION SURGERY. THE 3 HOLE ACETABULAR SHELL 48MM WAS REMOVED. THE OUTCOME OF THE PATIENT IS UNKNOWN. ADDITIONAL DETAILS HAVE NOT BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 11587195 ↗
• InjuryAug 27, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING SURGERY, SHELL LET THE SCREW GO ALL THE WAY THROUGH. SURGEON WAS ABLE TO REMOVE ALL AND ANOTHER SMITH AND NEPHEW CUP AND SCREW WERE USED. BACKUP DEVICES WERE THE SAME SIZE AS THE ORIGINAL IMPLANTS. NO INJURY REPORTED. A SLIGHT DELAY WHILE GETTING THE ORIGINAL IMPLANTS OUT OF THE PATIENT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

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

  MAUDE report 10461352 ↗
• InjuryJun 18, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A THA SURGERY, AFTER IMPLANTING THE 48 MM R3 3-HOLE ACETABULAR SHELL, THE LINER COULD NOT BE IMPLANTED. THE PROCEDURE WAS CONCLUDED WITH A 50 MM SHELL FROM SMITH AND NEPHEW. SURGERY WAS DELAYED LESS THAN 30 MIN. THE PATIENT WAS NOT HARMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10171131 ↗
• InjuryNov 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS PARTICIPATING ON THE "(B)(6) STUDY" AND UNDERWENT A REVISION SURGERY OF THE HEAD, SHELL AND LINER DUE TO UNKNOWN REASONS.

  Patient problems: Injury

  MAUDE report 9375609 ↗
• InjuryOct 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS PARTICIPATING ON THE "MULTI-CENTER, RANDOMIZED CONTROLLED STUDY OF EFFICACY AND SAFETY OF THE OXINIUM DH TOTAL HIP REPLACEMENT SYSTEM IN SUBJECTS WITH NON-INFLAMMATORY ARTHRITIS STUDY" AND UNDERWENT A REVISION SURGERY OF THE HEAD, SHELL AND LINER DUE TO UNKNOWN REASONS.

  Patient problems: Injury

  MAUDE report 9187370 ↗
• InjuryNov 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT IN (B)(6) HOSPITAL, A SURGEON PERFORMED A HIP REPLACEMENT SURGERY. THE 48MM R3 ACETABULUM CUP WAS IN AN APPROPRIATE LOCATION ACCORDING TO FLUOROSCOPY. THEN THREE SCREWS WERE IMPLANTED, AND IMPLANTED 48MM CERAMIC INSERT. AFTER LOAD TEST, A SCREW WAS FOUND THROUGH THE OUTER CUP PROSTHESIS SCREW HOLE DIRECTLY INTO THE PELVIS. SUBSEQUENTLY THE SURGEON HAD A ACETABULUM SIDE "REVISON" SURGERY, REMOVED SIDE PROSTHESIS, FOUND THE SCREW HOLE DEFORMATION OF ACETABULUM PROSTHESIS. THEN FILE TO 54, OUTER CUP TRIAL IMPLANTED, IT WAS STABLE. AFTER THAT, 54 ACETABULUM PROSTHESIS AND CERAMIC INSERT WERE IMPLANTED.

  Patient problems: Injury

  MAUDE report 8107709 ↗
• MalfunctionNov 6, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING ARTIFICIAL HIP REPLACEMENT SURGERY, SCREWS WERE USED FOR FIXATION AND ONE OF THE SCREWS PASSED DIRECTLY THROUGH THE ACETABULUM CUP, SURGEON USED ANOTHER TWO SCREWS FOR FIXATION. ONE OF THE SCREWS WAS LEFT IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8044712 ↗
• InjuryApr 12, 2017Malposition of Device; Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE ACETABULAR CUP WHICH HAD TWISTED. IT WAS ALSO REPORTED THAT ACCORDING TO THE OP REPORT THE CUP HAS BEEN GOOD IMPLANTED AND HAD STABILITY.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6484792 ↗