R3 71339552Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010583086), received between Apr 6, 2018 and Jan 21, 2026 — classified as 8 injuries, 1 malfunction.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING A THA SURGERY, WHEN ONE (1) R3 0 DEG XLPE ACET LNR 32MM X 52MM WAS OPENED THE STERILE PACKAGING INSIDE WAS NOT SEALED, THEREFORE THE POLY FELL THROUGH THE PLASTIC AND HIT THE GROUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130874 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER UNDERGOING A THR ON (B)(6) 2022, PATIENT EXPERIENCED INSTABILITY. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY, IN WHICH, THE R3 0 DEG XLPE ACET LNR 32MM X 52MM AND OXINIUM FEM HD 12/14 32MM +8 WERE EXCHANGE. IN ADDITION, SURGEON FOUND THERE WERE SCRATCHES ON THE HEAD FROM MAKING CONTACT WITH THE EDGE OF THE R3 CUP WHILST DISLOCATED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 19967466 ↗
• InjuryJun 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED RECURRENT DISLOCATIONS. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A R3 0 DEG XLPE ACET LNR 32MM X 52MM AND A OXINIUM FEM HD 12/14 32MM +0 WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 19500162 ↗
• InjuryAug 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 FEVER AND INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021, IN WHICH THE R3 0 DEG XLPE ACET LNR 32MM X 52MM WAS EXCHANGED. CURRENT HEALTH STATUS OF PATIENT. IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12319128 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2021 TO INSTALL A CONSTRAINED LINER BECAUSE OF RECURRING DISLOCATION. THE PATIENT ADMITTED TO BEING NON COMPLIANT. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020. ACETABULAR LINER AND FEMORAL HEAD WERE THE DEVICES EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11283673 ↗
• InjuryJan 13, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A THR PROCEDURE, THAT THE R3 0 DEGREES XLPE ACET LNEER32MM X 52MM HAS NOT ANCHORED ITSELF IN THE PAN. TRIED 4 TIMES AND THEN SWITCHED TO ANOTHER INLAY 36/52 XLPE. INSTRUMENTS INSIDE THE PATIENT. THERE WAS NO DELAY. PROCEDURE WAS FINISHED WITH A BACK UP DEVICE. THIS PROBLEM HAS ALSO OCCURRED IN THE PAST WITH OTHER R3 OPERATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167940 ↗
• InjuryDec 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HIP REVISION SURGERY WAS PERFORMED DUE TO SINKING OF THE HIP. LINER AND BALL HEAD EXCHANGED.

  Patient problems: Injury

  MAUDE report 9396039 ↗
• InjuryApr 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A POSTOPERATIVE INFECTION HAS OCCURRED IN THE PATIENT WHO RECEIVED THESE IMPLANTS. THE SURGEON INFORMED THE SALES REP ABOUT THIS.

  Patient problems: Unspecified Infection

  MAUDE report 8507258 ↗
• InjuryApr 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO DISLOCATION. THE HEAD AND THE LINER WERE REMOVED.

  Patient problems: Joint Dislocation

  MAUDE report 7405183 ↗

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.