R3 71337650Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 03596010598486), received between Dec 21, 2017 and Aug 23, 2024 — classified as 21 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A THA SURGERY, ONE (1) R3 20 DEG XLPE ACET LNR 32MM X 50MM COULD NOT BE LOCKED TIGHTLY. AFTER THREE ATTEMPTS, IT WAS REMOVED USING PLIERS. THE PROCEDURE RESUMED, AFTER A SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20053696 ↗
• InjuryNov 24, 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 AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED INFECTION. AS A RESULT OF THIS ADVERSE EVENT, A WASHOUT AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, IN WHICH A R3 20 DEG XLPE ACET LNR 32MM X 50MM AND A COCR 12/14 FEM HEAD 32 - 3 WERE EXCHANGED. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 18204380 ↗
• MalfunctionAug 3, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A THA SURGERY, AN R3 20 DEG XLPE ACET LNR 32MM X 50MM AND AN R3 3 HOLE ACET SHELL 50MM WERE PLANNED TO BE USED, BUT IT WAS FOUND THAT THE OUTER CUP AND INNER LINER DID NOT GET LOCKED. THERE WAS NOT OBVIOUS CHANGE IN THE MECHANISM. THE 50 MM SHELL AND LINER WERE REMOVED. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17455562 ↗
• InjuryJul 4, 2022Adverse 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, PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022 WERE THE HEAD AND LINER WERE EXCHANGED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 14910942 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR PROCEDURE HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT REQUIRED REVISION SURGERY TO EXPLANT THE R3 20 DEG XLPE ACET LNR 32MM X 50MM BECAUSE OF AN INFECTION. DURING THIS PROCEDURE, A WASHOUT WAS ALSO PERFORMED. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14713741 ↗
• InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR WAS PERFORMED ON (B)(6) 2022, THE PATIENT PRESENTED RECURRENT DISLOCATION. THEREFORE, A REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2022 IN ORDER TO TREAT THIS ADVERSE EVENT. IT IS UNKNOWN IF THE REVISION WAS ACTUALLY PERFORMED. FURTHER INFORMATION IS UNKNOWN AT THE MOMENT.

  Patient problems: Joint Dislocation

  MAUDE report 13734306 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TOTAL HIP REPLACEMENT WAS PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021, ALONG WITH A WASHOUT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 13153150 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED THREE HIP DISLOCATIONS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DURING THE SURGERY THE FEMORAL HEAD AND THE LINER WERE EXCHANGED AS PLANNED TO ACHIEVE STABILITY THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12111892 ↗
• MalfunctionJul 1, 2021Fitting Problem; Defective Device; Fitting Problem; Defective Device

  IT WAS REPORTED THAT DURING THR, THE 20 DEG XLPE ACET LNR 32MM X 50MM WOULD NOT SEAT WHILE INSIDE THE PATIENT AND THEN WAS DAMAGED. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12105164 ↗
• MalfunctionJun 28, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING THR SURGERY, AN R3 20 DEG XLPE ACET LNR 32MM X 50MM COULDN'T BE LOCKED AFTER TRYING SEVERAL TIMES. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. THE EVENT RESULTED IN AN UNPLANNED INCREASE OF 10 MINUTES OF SURGERY TIME, INCREASED THE PATIENT'S BLOOD LOSS AND RISK OF INFECTION. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12077050 ↗
• InjuryMay 13, 2021Adverse 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 AN INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. THE 20 DEG XLPE ACET LNR 32MM X 50MM WAS EXPLANTED. DURING WASHOUT + CALCIUM SULPHATE BEADS PROCEDURE THE 3 HOLE HA CTD ACET SHELL 50MM APPEARED LOOSE, WITH OSTEOLYSIS ALSO SEEN SUPEROLATERAL IN THE ACETABULUM/ILIUM. THE COCR 12/14 FEM HEAD 32 + 0 AND TWO UNIDENTIFIED SCREWS WERE ALSO EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 11821275 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A PRIMARY RIGHT THR, THE PATIENT PRESENTED PAIN IN THE JOINT, PSEUDOTUMOR FORMATION AND MECHANICAL LOOSENING OF THE JOINT PROSTHESIS. A REVISION SURGERY WAS PERFORMED TO EXPLANT A SMF STEM WITH STIKTITE SZ 2, OXINIUM FEMORAL HEAD 12/14 32MM -3 AND A R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Laxity; Laceration(s); Metal Related Pathology; Osteolysis; Pain; Unequal Limb Length

  MAUDE report 11736182 ↗
• InjuryApr 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIMENTED MULTIPLE DISLOCATIONS RECENTLY. THIS ADVERSE EVENT WAS ADDRESSED THROUGH REVISION SURGERY TO EXCHANGE LINER AND HEAD. GIVEN THAT THE SIZE OF R3 CUP IS 50 MM AND, THEREFORE, NOT ABLE TO TAKE A CONSTRAINED LINER, IT THE R3 CUP WAS ALSO REMOVED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 11722120 ↗
• MalfunctionOct 30, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT THE LINER CAN NOT BE LOCKED. SURGEON TRIED SEVERAL TIMES BY CLEANING SURGICAL SITE AND ADJUST POSITION, FINALLY THE SURGERY WAS COMPLETED BY CHANGE ANOTHER LINER (FROM SMITH AND NEPHEW) THIS ONE CAN BE LOCKED EASILY. THERE WAS A DELAY OF 40 MINUTES. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10766931 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED BECAUSE THE PATIENT HAD DISLOCATED SEVERAL TIMES WITH MOSTLY CLOSED REDUCTIONS DOING THE TRICK. AN OPEN REDUCTION WAS ALSO ATTEMPTED AS A LAST RESORT. ON OPENING THE WOUND, IT WAS VERY CLEAR THAT THE ACETABULAR COMPONENT WAS PROPERLY LOOSE CAUSING MUCH DISCOMFORT FOR THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Pain

  MAUDE report 10685023 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9860551 ↗
• InjuryMar 13, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO LOOSENING. THE R3 20-DEGREE XLPE ACETABULAR LINER 32 MM ID X OD 50MM WAS EXPLANTED. THE PATIENT IS ALSO COMPLAINING ABOUT PAIN AND FEELING STRANGE.

  Patient problems: Injury

  MAUDE report 9828500 ↗
• MalfunctionNov 25, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY THE OUTER CUP WAS IMPLANTED AND THE LINER CANNOT BE LOCKED. ANOTHER CUP AND LINER WERE USED TO COMPLETE THE SURGERY. TWO HOURS OF DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9372686 ↗
• MalfunctionOct 28, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING THE THR THE LINER WAS IMPACTED FOR HALF AN HOUR TO FIX IT. A DELAY OF 30 MINUTES TO 1 HOUR REPORTED. NO PATIENT INJURIES REPORTED. NO S&N BACKUP WAS REQUIRED AS THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9247970 ↗
• InjuryFeb 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A REVISION SURGERY WAS PERFORMED DUE TO AN INFECTION AND THE POLY WAS CHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 8334100 ↗
• InjuryDec 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY TO REMOVE THE LINER WAS PERFORMED DUE TO AN INFECTION. AN OXINIUM HEAD WAS ALSO REMOVED AND WAS REPORTED UNDER 1020279-2018-02676.

  Patient problems: Unspecified Infection

  MAUDE report 8135637 ↗
• InjuryNov 29, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO EXCHANGE LINER DUE TO IT WAS LOOSE AND NOT PROPERLY FIXED INTO THE CUP CAUSING PAIN AND DISCOMFORT TO PATIENT.

  Patient problems: Discomfort; Failure of Implant; Injury; Pain

  MAUDE report 8115192 ↗
• InjuryNov 15, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT FELL AND DISLOCATED HER HIP. SURGEON PERFORMED A REVISION SURGERY TO CHANGE THE HEAD AND THE POLY AS WELL IN CASE OF DAMAGE DUE TO THE DISLOCATION.

  Patient problems: Injury

  MAUDE report 8074496 ↗
• InjurySep 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO STEM LOOSENING. THE STEM, THE LINER AND THE FEMORAL HEAD WERE EXPLANTED.

  Patient problems: No Information

  MAUDE report 7844653 ↗
• InjuryAug 22, 2018Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION, AND DURING THE REVISION SURGERY, THE SURGEON NOTICED THAT A PART OF THE LINER HAD BEEN BROKEN.

  Patient problems: No Information

  MAUDE report 7805877 ↗

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.