R3 71339548Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03596010598790), received between Dec 21, 2017 and Sep 17, 2024 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP CONVERSION THA SURGERY ON (B)(6) 2021, DUE TO A FAILED CEPHALOMEDULLARY NAILING SYSTEM. DURING THE REVISION SURGERY, THE PRIMARY NAILING SYSTEM (UNKNOWN IDENTITY) WAS EXPLANTED AND REPLACED WITH A THA ACETABULAR REDAPT SYSTEM AND A REDAPT FEMORAL SYSTEM. THE PATIENT SUFFERED FROM A DEEP WOUND INFECTION AND REQUIRED A REVISION SURGERY OF THE RIGHT PROSTHESIS ON (B)(6) 2021. DURING THIS REVISION, THE FEMORAL HEAD AND THE ACETABULAR LINER WERE EXPLANTED. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 20238710 ↗
• InjuryMar 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, IT WAS DISCOVERED ON THE X-RAY THAT THE R3 0 DEG XLPE ACET LNR 32MM X 48MM HAD DISASSOCIATED. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON THE SAME DAY TO REPLACE THE LINER AND CUP. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13858321 ↗
• MalfunctionMay 12, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A THR THE R3 0 DEG XLPE ACET LNR 32MM X 48MM DID NOT LOCK ON THE ACETABULAR CUP PROPERLY. NO SURGICAL DELAY WAS REPORTED AND THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810877 ↗
• MalfunctionApr 19, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING SURGERY, THE R3 0 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X 48MM OUTER DIA DID NOT SNAP INTO THE CUP. A 5 MINUTES SURGICAL DELAY OCCURRED DUE TO OPENING A SECOND IMPLANT. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE WITHOUT INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683760 ↗
• InjuryMar 16, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INFECTION ONE MONTH AFTER THE PRIMARY PROCEDURE. R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 9833778 ↗
• InjuryNov 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS PARTICIPATING ON THE "(B)(6) STUDY" AND UNDERWENT A REVISION SURGERY OF THE HEAD, SHELL AND LINER DUE TO UNKNOWN REASONS.

  Patient problems: Injury

  MAUDE report 9375654 ↗
• InjuryOct 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS PARTICIPATING ON THE "MULTI-CENTER, RANDOMIZED CONTROLLED STUDY OF EFFICACY AND SAFETY OF THE OXINIUM DH TOTAL HIP REPLACEMENT SYSTEM IN SUBJECTS WITH NON-INFLAMMATORY ARTHRITIS STUDY" AND UNDERWENT A REVISION SURGERY OF THE HEAD, SHELL AND LINER DUE TO UNKNOWN REASONS.

  Patient problems: Injury

  MAUDE report 9187374 ↗
• InjuryAug 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. IT IS UNKNOWN THE REASON FOR THIS REVISION. LINER WAS REMOVED.

  Patient problems: Injury

  MAUDE report 8862831 ↗
• InjuryMay 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD RECENT ONSET OF PAIN, BLOOD TEST AND ASPIRATION WERE NEGATIVE FOR INFECTION. LINER AND HEAD WERE REMOVED, WASHOUT PERFORMED, SPECIMENS TAKEN NO OBVIOUS INFECTION.

  Patient problems: Pain

  MAUDE report 8661087 ↗
• InjuryDec 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ASPIRATION ON THE LEFT HIP DUE TO AN INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8139800 ↗
• InjuryJul 5, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT SUFFERED AN ACETABULAR SHELL DISLOCATION. THE EVENT WAS RESOLVED WITH REVISION SURGERY. CUP HAS BEEN DESTROYED AND IS NOT AVAILABLE FOR INVESTIGATION.

  Patient problems: Joint Dislocation

  MAUDE report 7664710 ↗
• InjuryApr 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO DISLOCATION. SURGEON OPENED UP SOFT TISSUE LAYERS TO ALLOW HIP TO BE DISLOCATED. THE R3 LINER AND THE FEMORAL HEAD WERE REMOVED.

  Patient problems: Joint Dislocation

  MAUDE report 7431730 ↗
• InjuryApr 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY AS CONSEQUENCE OF A FRACTURED ACETABULUM. NO FALL OR OTHER INCIDENT OCCURRED.

  Patient problems: Hip Fracture

  MAUDE report 7390953 ↗
• InjuryDec 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO DISLOCATION, ALL PARTS WERE REMOVED.

  Patient problems: Joint Dislocation

  MAUDE report 7140321 ↗

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.