R3 71335752Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 03596010598332), received between May 26, 2017 and Apr 1, 2026 — classified as 41 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED A PERIPROSTHETIC FRACTURE OF THE HIP. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2026, IN WHICH THE R3 20 DEG XLPE ACET LNR 36MM X 52MM, OXINIUM FEM HD 12/14 36 MM M/+4 AND THE CPCS COCR PRI HO 12/14 SZ 0 WERE REMOVED. AFTER THE FEMUR WAS REVISED, THE SURGEON CONVERTED THE R3 STANDARD LINER TO A DUAL MOBILITY OR30 FOR EXTRA STABILITY. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information; Periprosthetic fracture

  MAUDE report 24753328 ↗
• InjuryDec 3, 2025Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THR SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE THE PATIENT EXPERIENCED INFECTION, THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2025 IN WHICH THE R3 20 DEG XLPE ACET LNR 36MM X 52MM AND OXINIUM FEM HD 12/14 36MM +0 WERE EXCHANGED AND THE SURGEON PERFORMED A WASHOUT. THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 23705366 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED RECURRENT HIP DISLOCATIONS. THE DISLOCATIONS WERE MANAGED ON THREE SEPARATE OCCASIONS WITH CLOSED REDUCTION PROCEDURES. DUE TO THE RECURRENCE, THE SURGEON IS CONSIDERING REVISING THE LINER TO A DUAL MOBILITY PROSTHESIS. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 23080783 ↗
• 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 THR SURGERY PERFORMED ON (B)(6) 2024, THE PATIENT DISLOCATED HIS HIP ON (B)(6) 2024. THE PATIENT IS SCHEDULED FOR A CUP REVISION NEXT WEEK. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 20842913 ↗
• InjuryDec 3, 2024Adverse 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 AN UNKNOWN DATE, DUE TO IMPINGEMENT DETERMINED BY THE SURGEON HE DECIDED TO PERFORM A POLY SWAP TO CORRECT THE ISSUE ON (B)(6) 2024, IN WHICH THE R3 20 DEG XLPE ACET LNR 36MM X 52MM WAS REMOVED AND CONVERTED TO AN OR3O CONSTRUCT. PATIENT LEFT SURGERY IN GOOD HEALTH.

  Patient problems: Joint Impingement

  MAUDE report 20833276 ↗
• InjurySep 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER UNDERGOING A THR ON (B)(6) 2024, PATIENT EXPERIENCED DISLOCATION. THIS HAPPENED THREE TIMES. SURGEON SUSPECTED WAS ALCOHOL MISUSED AND DID NOT FAULT THE IMPLANTS. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE LINER, SHELL AND HEAD WERE EXCHANGED. SURGEON CONVERTED TO J&J CONSTRAINED LINER. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 20304395 ↗
• InjuryOct 17, 2023Degraded; Fracture; Biocompatibility; Degraded; Fracture; Biocompatibility

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A PRIMARY THR LEFT HIP SURGERY ON (B)(6) 2017 AND SUBSEQUENTLY SUFFERED FROM SUBLUXATION LEFT HIP WITH METALLOSIS AND DISRUPTION OF THE HIP LINER AND FEMORAL HEAD. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2018 TO EXPLANT THE R3 20 DEG XLPE ACET LNR 36MM X 52MM AND OXINIUM FEM HD 12/14 36 MM +0. GROSS PATHOLOGY SHOWED SIGNIFICANT ALKALOSIS DUE TO CHRONIC SUBLUXATION AND WEAR OF THE FEMORAL HEAD. FRAGMENTATION OF THE ACETABULAR LINER. ALL VISIBLE DEBRIS WERE REMOVED, AND ELECTROCAUTERY WAS USED FOR HEMOSTASIS. COMPLETING TRIAL RANGE OF MOTION WAS AGAIN PERFORMED SHOWING FLEXION TO 90° WITH 60° OF EXTERNAL ROTATION EXCELLENT STABILITY AND SLEEPER POSITION. THE PATIENT WAS PLACED IN ABDUCTION PILLOW AND REMOVED FROM THE OPERATING TABLE TO RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant; Joint Laxity; Metal Related Pathology; Subluxation

  MAUDE report 17950690 ↗
• InjuryOct 6, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING THR SURGERY, THE R3 20 DEG XLPE ACET LNR 36MM X 52MM WAS NOT LOCKING IN THE R3 ACETABULAR CUP. THE PROCEDURE WAS COMPLETED, WITH A SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15554261 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR PERFORMED ON (B)(6) 2022, THE PATIENT HAD AN INFECTION. A REVISION SURGERY WAS ADDRESSED TO EXPLANT ALL THE IMPLANTS (OXONIUM FEM HD 12/14 32 MM +4, R3 20 DEG XLPE ACET LNR 36 MM X 52 MM, R3 0 HOLE HA CTD ACET SHELL 52 MM, REF INTERFIT THRD HOLE COVER AND POLARSTEM STEM LAT.TI/HA 1 NON-CEM) AND INSERT CEMENT SPACERS. FURTHER INFORMATION IS UNKNOWN AT THE MOMENT.

  Patient problems: Unspecified Infection

  MAUDE report 15257969 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLAINTIFF SUFFERED FROM A RIGHT HIP DISLOCATION AND REQUIRED A CLOSED REDUCTION UNDER MODERATE SEDATION ON (B)(6) 2022. X-RAY DEMONSTRATED THAT THE FEMUR WAS DISPLACED SUPERIOR AND LATERAL TO THE ACETABULAR CUP. THE PATIENT TOLERATED THE PROCEDURE WELL. THIS PATIENT HAS A HISTORY OF A PRIMARY RIGHT HIP R3-THA SURGERY ON (B)(6) 2017 AND A SUBSEQUENT REVISION SURGERY ON (B)(6) 2021.

  Patient problems: Joint Dislocation

  MAUDE report 15136525 ↗
• MalfunctionMay 23, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING SET UP FOR A THR PROCEDURE, THE R3 20 DEG XLPE ACET LNR 36MM X 52MM SECOND LAYER OF STERILE PACKAGING WAS NOT SEALED. AS THIS WAS NOTICED BEFORE PROCEDURE, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14480429 ↗
• InjuryApr 26, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED (B)(6) 2022, IT WAS NOTICED THAT THE LINER WAS NEVER SEATED IN SHELL, CAUSING THE HEAD AND CUP TO RUB. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2022 CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. THE FEMORAL HEAD PRESENTED SIGNIFICANT WEAR.

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

  MAUDE report 14212434 ↗
• InjuryMar 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2022, REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REPLACE THE R3 20 DEG XLPE ACET LNR 36MM X 52MM DUE TO DISLOCATION. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 13690283 ↗
• 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 SURGERY, HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED A SUPERFICIAL INFECTION THAT PROGRESSED TO THE JOINT AFTER HER ORIGINAL DRAINAGE AND WASHOUT WERE CANCELED DUE TO A POSITIVE COVID TEST. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION TO EXCHANGED AND EXPLANT THE R3 20 DEG XLPE ACET LNR 36MM X 52MM WITH THE SAME SIZE. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 13619891 ↗
• InjuryFeb 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  US LEGAL IT WAS REPORTED THAT 4 WEEKS AFTER THE PATIENT UNDERWENT A FIRST REVISION SURGERY OF THE LEFT HIP DUE TO METALLOSIS ON (B)(6) 2018, THE PATIENT SUFFERED FROM A DISLOCATION OF THE HIP AND PRESENTED PAIN. THE PATIENT UNDERWENT A FAILED CLOSED REDUCTION ON (B)(6) 2018 AND UNDERWENT AND OPEN REDUCTION WITH REVISION ON (B)(6) 2018 TO ADDRESS THE REPORTED DISLOCATION. DURING THE REVISION SURGERY, A SN POLY LINER AND A FEMORAL HEAD FROM A COMPETITOR¿S WERE EXPLANTED FROM THE PATIENT AND REPLACED WITH NEW ONES. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 13429312 ↗
• InjuryAug 10, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AFTER A THA, (DATE UNKNOWN), A REVISION SURGERY WAS PERFORMED FOR RE-POSITIONING ON (B)(6) 2021. R3 3 HOLE ACETABULAR SHELL 52MM AND R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM WERE EXTRACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304803 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TOTAL HIP ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021, WHERE THE 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM ((B)(4)) AND THE COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4 ((B)(4)) WERE REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12053613 ↗
• InjuryMar 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY TOOK PLACE ON (B)(6) 2021 DUE TO AN INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 11573370 ↗
• InjuryMar 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MEDICAL INDICATED REVISION SURGERY ON THE RIGHT HIP ON (B)(6) 2018. THE REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THE HEAD AND LINER WERE EXPLANTED. THE INDEX SHELL AND THE COMPETITOR STEM REMAIN IMPLANTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Hematoma; Joint Dislocation; Metal Related Pathology; Nerve Damage

  MAUDE report 11541434 ↗
• InjuryDec 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE FEMORAL HEAD WAS REMOVED AND REPLACED ON NOVEMBER (B)(6) 2020. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 10979869 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO-STAGES REVISION SURGERY WAS PERFORMED TWO YEARS AFTER PRIMARY PROCEDURE DUE TO LOOSENING AND INFECTION WITH PLACEMENT OF ANTIBIOTIC SPACERS.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10551918 ↗
• InjuryJul 3, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PROCEDURE TKA, THE CUP WAS MISS FIT (INSIDE THE PATIENT). THE PROCEDURE HAD A DELAY BETWEEN 0-30 MIN. THE PATIENT PRESENTED AN UNSPECIFIED INJURY. THE PROCEDURE WAS FINISHED WITH A BACKUP FROM SMITH&NEPHEW. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10230290 ↗
• InjuryMay 4, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT HAS ALZHEIMER¿S AND DOES NOT COMPLY WITH MOVEMENT RESTRICTIONS FOR THA. SHE CONTINUOUSLY DISLOCATES AND THE SURGEON DECIDED TO REVISE TO A CONSTRAINED LINER. THERE ARE NO MEDICAL RECORDS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 10022593 ↗
• InjuryApr 17, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT HAD SMITH+NEPHEW COMPONENTS SINCE (B)(6) 2019. REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO INSTABILITY AND CHRONIC DISLOCATION FROM THE RADICLE TISSUE DEBRIDEMENT. THE CUP, LINER, SCREW AND FEMORAL HEAD WERE REMOVED.

  Patient problems: Injury

  MAUDE report 9975134 ↗
• InjuryMar 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER A THR PROCEDURE, THE PATIENT HAS UNDERGONE RECURRENT DISLOCATIONS DUE TO SOFT TISSUE LAXITY. FOR THIS REASON, REVISION SURGERY WAS PERFORMED AND THE 36 MM ID 52 MM OD R3 XLPE LINER WAS REMOVED AND REPLACED WITH A CONSTRAINED R3 INSERT 22MM ID 52MM OD REF 71339152, LOT 18CM20359A TO SUPPORT THE SOFT TISSUE LAXITY. ALL EXPLANTED IMPLANTS HAVE BEEN DISCARDED.

  Patient problems: Joint Dislocation

  MAUDE report 9824362 ↗

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-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.
• 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.