R3 ACETABULAR 71335560Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03596010598288), received between Jul 6, 2017 and Aug 30, 2023 — classified as 12 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2023Degraded; Biocompatibility; Device Dislodged or Dislocated; Degraded; Biocompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED, AFTER A LEFT THA PROCEDURE WAS PERFORMED ON THE (B)(6) 2011, THE PATIENT EXPERIENCED A DISLOCATION, AND A CT SCAN WORKUP SHOWED A LARGE PSEUDOTUMOR. A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2013 TO TREAT THIS ADVERSE EVENT. DURING THE REVISION SURGERY, A LARGE METALLOSIS AREA WAS FOUND AND THE TOP SURFACE OF THE ACETABULAR CUP WAS WORN AWAY. THE PATIENT SUPPORTED THE PROCEDURE AND WAS TAKEN TO THE RECOVERY ROOM.

  Patient problems: Joint Dislocation; Metal Related Pathology; Solid Tumor

  MAUDE report 17650836 ↗
• InjuryJun 6, 2023Adverse 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) 2021, THE PATIENT EXPERIENCED ACUTE BLOOD LOSS ANEMIA. THIS ADVERSE EVENT STARTED THE SAME DAY OF THE SURGERY AND IT WAS TREATED BY TRANSFUSION OF A PACKED RBC 1 UNIT. PATIENT WAS RECOVERED.

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17071744 ↗
• InjuryMay 12, 2023Migration; Migration

  IT WAS REPORTED THAT, AFTER A R3-THA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT HIP ON (B)(6) 2010, THE PATIENT HAS BEEN EXPERIENCING SEVERE RIGHT HIP PAIN AND LIMITED AMBULATION WITH DECREASED RANGE OF MOTION. AFTER THIS PROCEDURE, SEVERAL RIGHT HIP RADIOGRAPHS HAVE BEEN TAKEN WHICH REVEAL AN OVERALL STABLE APPEARANCE WITHOUT SIGNIFICANT CHANGES, EVIDENCE OF LOOSENING OR PRESENCE OF FRACTURES. A CHROMIUM AND COBALT LEVELS IN BLOOD TEST CONDUCTED ON (B)(6) 2021 REVEALED CONCENTRATIONS BELOW 3 NG/ML FOR BOTH IONS. IN ADDITION, ON (B)(6) 2020, A FROG LEG ANTEROPOSTERIOR RADIOGRAPH OF THE RIGHT HIP REVEALED SUPERIOR MEDIAL MIGRATION OF THE ACETABULAR COMPONENT. TO TREAT THE ONGOING RIGHT HIP PAIN, THE PATIENT UNDERWENT A FEMORAL AND OBTURATOR NERVE BLOCK PROCEDURE UNDER FLUOROSCOPIC GUIDANCE ON (B)(6) 2020. DURING THIS PROCEDURE, THE ARTICULAR BRANCH OF THE FEMORAL AND OBTURATOR NERVE WAS BLOCKED WITH 1 ML OF 0.25% BUPIVACAINE, RESPECTIVELY. IN ADDITION, ON (B)(6) 2021, THE PATIENT UNDERWENT A RADIOFREQUENCY ABLATION OF THE ARTICULAR BRANCH OF BOTH NERVES WITH THE SAME DIAGNOSIS OF PERSISTENT RIGHT HIP PAIN. ON (B)(6) 2023, IT WAS STATED THAT THE PATIENT WILL UNDERGO A RIGHT

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Fall; Inadequate Pain Relief; Loss of Range of Motion; Metal Related Pathology; Osteolysis

  MAUDE report 16919654 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA WAS PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED SEPSIS IN THE HIP JOINT WITH IMPLANTS IMPLANTED. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection; Sepsis

  MAUDE report 16746665 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A FIRST REVISION SURGERY HAD BEEN PERFORMED ON PLAINTIFF'S LEFT HIP ON (B)(6) 2014, THE PLAINTIFF CHRONIC RECURRENT DISLOCATIONS THAT LED TO A SECOND REVISION SURGERY, WHICH WAS PERFORMED ON (B)(6) 2015 TO TREAT THE ADVERSE EVENT. THE LINER, THE CUP, AND THE FEMORAL HEAD WERE REPLACED. THE PLAINTIFF'S OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 12370929 ↗
• InjuryNov 27, 2020Migration; Migration

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED, A SCREW WENT THROUGH THE R3 3 HOLE ACET SHELL 60 MM HOLE. IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS DIAGNOSED AND IF IT HAS BEEN ALREADY ADDRESSED. THE PATIENT OUTCOME IS ALSO UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 10915077 ↗
• InjuryApr 9, 2019Fitting Problem; Connection Problem; Fitting Problem; Connection Problem

  IT WAS REPORTED THAT DURING THE TOTAL HIP REPLACEMENT SURGERY, AFTER MEASUREMENT, THE INSERT 60MM WAS CHOSEN TO BE USED. WHILE IMPLANTING, THE INSERT WAS COMPLETELY INSIDE THE CUP, BUT IT WAS NOT CLOSE TO FIT, IT COULD STILL BE MOVED. A CALL FOR HELP FROM THE S&N WAS DONE AND IT WAS INFORMED THAT IT COULD BE RE-IMPLANTED AFTER SOAKING IN ICE WATER, BUT AFTER SOAKING IN THE ICE WATER FOR 5 MINUTES, THE SITUATION OCCURRED AGAIN. THEN, IT WAS TRIED TO SOAK IT IN HOT WATER, AND IT STILL COULD NOT BE TIGHTENED. AFTER REPEATED TRIALS FOR MORE THAN AN HOUR, THE PATIENT HAD ALREADY HAD A LOT OF BLEEDING. INQUIRING THE S&N AGAIN, IT WAS DECIDED TO CHANGE THE CUP AND FAILED AGAIN. AT THAT TIME, THE PATIENT HAD MORE BLOOD LOSS AND ARRHYTHMIA. THEN THE SURGEON HAD TO TAKE OUT THE ACETABULAR PROSTHESIS, REPLACED IT WITH THE 62MM ACETABULAR CUP PROSTHESIS, AND SUCCESSFULLY IMPLANTED THE 62MM HIGH CROSS-LINKED LINER. THE SURGERY WAS COMPLETED AFTER MORE THAN 2 HOURS DELAY.

  Patient problems: Injury

  MAUDE report 8496451 ↗
• InjuryMar 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO METALLOSIS.

  Patient problems: Injury

  MAUDE report 8410197 ↗
• InjuryFeb 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT THAT DURING THE SCREW INSERTION WAS UNSUCCESSFUL. RADIOGRAPHY CONFIRMED THE TIP OF THE CANCELLOUS SCREW PENETRATED THROUGH THE ILIAC CORTEX INTO ABDOMEN.

  Patient problems: Injury

  MAUDE report 8308598 ↗
• InjuryOct 10, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A HIP REVISION WAS PERFORMED DUE TO DELAYED HIP PROSTHESIS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7954123 ↗
• InjuryJun 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AN INFECTION, SO WE REMOVED THE IMPLANT AND PUT IN AN ANTIBIOTIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 7653905 ↗
• InjuryJul 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH A CLINICAL STUDY THAT PATIENT WAS TREATED WITH MEDICATION/ ORTHOTICS DUE TO INCREASE IN LEFT HIP PAIN. SEVERITY WAS NOTED AS MODERATE AND OUTCOME OF THIS EVENT WAS NOTED AS ONGOING/UNRESOLVED.

  Patient problems: Pain

  MAUDE report 6688876 ↗