R3 71335760Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010598370), received between Sep 6, 2018 and May 5, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K113848, K211176); they may or may not involve this specific model.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THA SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED RECURRENT DISLOCATIONS ON AN R3 CUP. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2026, IN WHICH THE R3 20 DEG XLPE ACET LNR 36MM X 60MM AND THE COCR 12/14 FEM HEAD 36MM +4 WERE EXCHANGED FOR DUAL MOBILITY FOR EXTRA STABILITY. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 25089345 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED A LUXATION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A R3 20 DEG XLPE ACET LNR 36MM X 60MM, R3 3 HOLE ACET SHELL 60MM AND OXINIUM FEM HD 12/14 36 MM L/+8 WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Subluxation

  MAUDE report 24333106 ↗
• InjuryFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT REPORTED AN INFECTION. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2022 TO REPLACE THE R3 20 DEG XLPE ACET LNR 36MM X 60MM. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 13540242 ↗
• InjuryMay 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR PERFORMED IN (B)(6) 2013, AS A REVISION SURGERY FOR INFECTION OF NON SMITH AND NEPHEW DEVICES, THE PATIENT EXPERIENCED PAIN IN THE RIGHT HIP AND A POSSIBLE RECURRENT INFECTION WAS SUSPECTED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THESE ADVERSE EVENTS. THE OXINIUM FEM HD 12/14 36 MM +0 ((B)(4)), THE R3 20 DEG XLPE ACET LNR 36MM X 60MM ((B)(4)), THE CPCS COCR PRIM HO 12/14 SZ 5 ((B)(4)), AND THE CPCS DIST CENT SZ 16MM ((B)(4)) WERE EXPLANTED. IT IS UNKNOWN WHICH NEW DEVICES WERE IMPLANTED. NO OTHER COMPLICATIONS WERE REPORTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 11861818 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 36/60 20 DEGREE LINER WAS PLACED IN A 60MM R3 HOUSING. ONCE THE SURGEON HAD IMPACTED THE LINER, HE PUSHED IT AWAY AND THE BLOOD/FLUID SQUIRTED OUT FROM BETWEEN THE LINER AND THE SHELL. AFTER THAT, IT IMPACTED THE LINER A LITTLE MORE AND HE CONTINUED WITH THE PROCEDURE (WITH THE SAME DEVICE). THERE WAS NO SMITH AND NEPHEW REPRESENTATIVE IN THE CASE.

  Patient problems: No Information

  MAUDE report 10188004 ↗
• InjuryJan 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A SUBSEQUENT RIGHT HIP REVISION SURGERY DUE TO SEPTIC HIP. LINER AND FEMORAL HEAD EXCHANGED.

  Patient problems: Failure of Implant

  MAUDE report 9610966 ↗
• 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 8495478 ↗
• InjurySep 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT WRONG LINER WAS IMPLANTED.

  Patient problems: Injury

  MAUDE report 7851140 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113848, K211176. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
• Z-1929-2013 · May 29, 2013 · Terminated
  R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic.
• Z-1928-2013 · May 29, 2013 · Terminated
  R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic.