R3 71339550Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 03596010598806), received between May 3, 2017 and Jun 2, 2022 — classified as 18 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2022Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging

  IT WAS REPORTED THAT, THE FIRST LAYER OF AN R3 0 DEG XLPE ACET LNR 32MM X 50MM PACKAGE WAS RECEIVED OPENED. AS THIS WAS NOTICED UPON SET-UP OR INSPECTION FOR THR SURGERY, THE PATIENT WAS NOT INVOLVED AT THAT MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14580824 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON 03-MAY-2022 TO WASHOUT THE HIP AND EXCHANGE THE R3 0 DEG XLPE ACET LNR 32MM X 50MM. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14520046 ↗
• InjuryDec 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER TOTAL HIP REPLACEMENT WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED IMPLANT DISLOCATION. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021, IN WHICH BOTH R3 0 DEG XLPE ACET LNR 32 MM X 50 MM AND OXONIUM FEM HD 12/14 32 MM -3 WERE REMOVED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13011254 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, TWO WEEKS AFTER A REVISION THR SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED PUS FROM THE WOUND. THE INFECTION WAS SOLVED VIA TWO-STAGE REVISION SURGERY, WHOSE FIRST LEG TOOK PLACE ON (B)(6) 2021. IMPLANTS WERE REMOVED WITHOUT ISSUE AND A CEMENT SPACER WAS IMPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Purulent Discharge

  MAUDE report 12829656 ↗
• InjurySep 14, 2021Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED, THE R3 0 DEG XLPE ACET LNR 32MM X 50MM BROKE AND BECOME DISLODGED. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY PERFORMED ON (B)(6) 2020, IN WHICH THE R3 0 DEG XLPE ACET LNR 32MM X 50MM AND OXINIUM FEM HD 12/14 32MM +0 WERE REPLACED. DUE TO REVISION SURGERY, THE PATIENT CURRENTLY EXPERIENCES SOME LEVEL OF PAIN AND DECREASED RANGE OF MOTION DAILY.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 12471519 ↗
• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED RECURRENT JOINT DISLOCATIONS. THE DISLOCATIONS WERE CAUSED BY THE OXINIUM FEM HD 12/14 32MM +4 DISLOCATING FROM THE R3 0 DEG XLPE ACET LNR 32MM X 50MM. THIS ADVERSE EVENT LED TO A REVISION SURGERY PERFORMED ON (B)(6) 2021, IN WHICH IT WAS CONFIRMED THAT THE R3 3 HOLE HA CTD ACET SHELL 50MM WAS WELL FIXED AND A SEVERE SCRATCH WAS NOTICED ON THE OXINIUM FEM HD 12/14 32MM +4. THE R3 0 DEG XLPE ACET LNR 32MM X 50MM AND OXINIUM FEM HD 12/14 32MM +4 WERE REPLACED, AND AS A CONSEQUENCE OF THAT REPLACEMENT, THE R3 3 HOLE HA CTD ACET SHELL 50MM HAD TO BE EXPLANTED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12311016 ↗
• InjuryJul 1, 2021Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED A DISASSOCIATION OF THE 0 DEG XLPE ACET LNR 32MM X 50MM ORIGINALLY IMPLANTED. THIS ADVERSE EVENT WAS SOLVED BY REPLACING THE LINER ON (B)(6) 2020 WITH A SMITH AND NEPHEW 32MM X 50MM 0 DEGREE LINER. PATIENT IS CURRENTLY STABLE.

  Patient problems: Discomfort; Failure of Implant; Inflammation; Joint Dislocation; Loss of Range of Motion; Pain

  MAUDE report 12104433 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER DAA THA SURGERY, THE PATIENT WAS IN PAIN FROM THE SECOND WEEK AND ONWARDS, FELT TIGHT ACROSS THE FRONT HIP, DID NOT HAD A GOOD RANGE OF MOVEMENT AND THE LEG ON THE OPERATIVE SIDE WAS SHORTER. A REVISION SURGERY WAS PERFORMED ON(B)(6) 2021 AND ALL THE COMPONENTS WERE EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Arthralgia; Loss of Range of Motion; Muscular Rigidity

  MAUDE report 11826657 ↗
• InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PRIMARY THR ON (B)(6) 2020 AND SHOWED SIGNS OF INFECTION AND THIS WAS CONFIRMED BY PATHOLOGY. REVISION SURGERY PERFORMED USING CPCS AND ALL POLY REFLECTION CUP WITH COPAL ANTIBIOTIC CEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 11349876 ↗
• InjuryJan 10, 2021Adverse 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, THERE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED TO REMOVE THE LINER. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 11144656 ↗
• InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF THR WAS PERFORMED. THE PATIENT WAS TAKEN IN FOR HIP PAIN AND POSSIBLE INFECTION. THE SURGEON PERFORMED IRRIGATION AND DEBRIDEMENT, AND THE R3 0 DEGREES XLPE ACETABULAR LINER 32MM X 50MM ((B)(4)) AND OXINIUM FEMORAL HEAD 12/14 32MM -3 ((B)(4)) WERE EXCHANGE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 10616905 ↗
• MalfunctionJul 7, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS LINER WILL NOT SIT CORRECTLY. EVENT OCCURRED DURING SURGERY. PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE AND NO DELAY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10242061 ↗
• InjuryMay 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR HAD BEEN PERFORMED, THE PATIENT HAD AN INTRA-ARTICULAR INFECTION. A REVISION SURGERY WAS PERFORM TO TREAT THIS ADVERSE EVENT. THE R3 XLPE ACETABULAR LINER WAS EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 10054651 ↗
• InjuryNov 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION, THE PATIENT HIP WAS PREPPED AND DRAPED JOINT OPENED SPECIMENS TAKEN, THE JOINT GOT LAVAGED AND DEBRIDED INTENSELY. THE FEMORAL HEAD AND POLY LINER WERE REMOVED. THE JOINT LAVAGED AGAIN WITH HYDROGEN PEROXIDE AND MORE SALINE SOLUTION. NEW LINER AND HEAD INSERTED. HIP REDUCED HIP CLOSED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 9281467 ↗
• InjuryJul 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. LINER AND FEMORAL HEAD WERE EXCHANGED.

  Patient problems: Joint Dislocation

  MAUDE report 8834686 ↗
• InjuryApr 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 DUE TO ONGOING PAIN. HEAD, CUP AND LINER WERE REMOVED; NEW DEVICES WERE INSERTED.

  Patient problems: Pain

  MAUDE report 8491860 ↗
• InjuryJan 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTS ILIOPSOAS TENDINITIS ON OPERATIVE HIP. THIS WAS FOUND AFTER SURGERY. DEVICE BACK UP NOT APPLICABLE AND DELAY DURING PROCEDURE IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 8266496 ↗
• InjuryOct 29, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND DISLOCATION.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 8017287 ↗
• InjuryOct 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY OF LEFT DAA TOTAL HIP RECONSTRUCTION DUE TO INFECTION - REMOVAL OF FEMORAL HEAD AND ACETABULAR LINER. WASHOUT.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 6960687 ↗
• InjuryMay 3, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO RIGHT HIP RECURRING DISLOCATION. PROCEDURE: REVISION RIGHT TOTAL HIP ARTHROPLASTY OF ACETABULAR COMPONENT AND FEMORAL HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 6541033 ↗

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.