R3 ACETABULAR 71331948Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010597724), received between Jun 2, 2020 and Feb 1, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2016 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED A MALALIGNMENT ¿ SOCKET / DISLOCATION/SUBLUXATION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2022. DURING THIS PROCEDURE, THE ACETABULAR CUP, MODULAR HEAD AND THE ACETABULAR LINER WERE EXPLANTED AND REPLACED WITH SIMILAR DEVICES. 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 AND AN R3 SHELL AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Deformity/ Disfigurement; Joint Dislocation

  MAUDE report 16280617 ↗
• InjuryJan 11, 2023Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT, AFTER A LEFT THR INDEX SURGERY PERFORMED ON (B)(6) 2016 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED THE LOOSENING OF THE ACETABULAR CUP AND UNEXPLAINED PAIN THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2017. DURING THIS PROCEDURE, THE ACETABULAR SHELL, ACETABULAR LINER AND FEMORAL HEAD WERE EXPLANTED AND REPLACED WITH A COMPETITORS ACETABULAR CONSTRUCT. 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: Arthralgia; Inadequate Osseointegration

  MAUDE report 16138509 ↗
• InjuryJun 16, 2022Improper or Incorrect Procedure or Method; Migration; Improper or Incorrect Procedure or Method; Migration

  IT WAS REPORTED THAT ON LITERATURE REVIEW "EARLY FAILURE OF THE POLARSTEM TOTAL HIP ARTHROPLASTY¿CAN THE AUSTRALIAN NJR TELL US THE FULL STORY?". ONE (1) PATIENT WHO INITIALLY UNDERWENT PRIMARY THR IMPLANTATION WITH A COMBINATION OF A CEMENTLESS COLLARED POLARSTEM AND AN R3 ACETABULAR CUP, REQUIRED AN ADDITIONAL SURGERY THIRTY ONE (31) DAYS POSTOPERATIVELY WITH ACETABULAR CUP EXCHANGE DUE TO SUSTAINED CENTRAL PROTUSION OF THIS IMPLANT. THE OUTCOME OF THIS PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14711142 ↗
• InjuryJun 11, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE R3 3 HOLE HA CTD ACET SHELL 48MM HAD NO GRIP. SURGERY WAS RESUMED, WITH A LESS THAN OR EQUAL TO 30 MINUTES DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. THE SURGEON REAMED UP THE ACETABULUM TO THE NEXT CUP SIZE AND IMPLANTED THE DEFINITE CUP. PATIENT WAS NOT HARMED AND HAD A GREAT OUTCOME IN THE END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14671933 ↗
• InjuryAug 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PRIMARY HIP REPLACEMENT ON 6-7-2020. REVISION SURGERY WAS PERFORMED DUE TO RECURRENT DISLOCATIONS (X-RAY ATTACHED). CUP/LINER/HEAD WERE REMOVED. SURGEON CHANGED VERSION AND LONGER HEAD TO RESTORE OFFSET/LEG LENGTH. SAME SIZE CUP/LINER INSERTED WITH SCREW 35MM LENGTH AND CENTRAL SCREW HOLE COVER. OX +4 HEAD 32MM IMPLANTED (LONGER THAN PREVIOUS).SURGEON COMMENTED REASON FOR REVISION WAS DUE TO CUP MALPOSITIONING (TOO ANTEVERTED) AND NOT ENOUGH OFFSET/LENGTH. NOT A PRODUCT FAULT.

  Patient problems: Injury

  MAUDE report 10423615 ↗
• InjuryJun 2, 2020Break; Break

  IT WAS REPORTED THAT DURING LEFT THR PROCEDURE, ON INSERTION THE SHELL WAS POSITIONED AND IMPACTED WITH MALLET ONTO R3 SHELL IMPACTOR/POSITIONER AS PER STANDARD TECHNIQUE. THE SHELL IMPACTOR BECAME LOOSE AND THE TIP (ABOUT 1-2MM) SHEARED OFF IMPACTOR THREAD AND STAYED WEDGED IN THE SHELL APEX. THE SHEARED OFF TIP WAS ATTEMPTED TO BE REMOVED BUT SURGEON COULD NOT TWIST OUT. SURGEON DECIDED TO REMOVE SHELL AS HE WASN'T HAPPY LEAVING TIP IN AND WASN'T SURE IF SHELL WAS FULLY SEATED AND STABLE. PROCEDURE WAS COMPLETED WITH OTHER 48MM SHELL. 3-5 MINUTES DELAYED REPORTED.

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

  MAUDE report 10110902 ↗