R3 71337660Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010598530), received between May 22, 2020 and Dec 8, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Connection Problem” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2021Material Discolored; Adverse Event Without Identified Device or Use Problem; Material Discolored; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR WITH A R3 20 DEG XLPE ACET LNR 32MM X 60MM, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO HYBRID HIP CONSTRUCT FOR INSTABILITY. SURGEON OPENED AND IDENTIFIED HOW HIP WAS DISLOCATING, THEREFORE, REMOVED FEMORAL HEAD AND LINER. ALSO, HE HIGHLIGHTED A DISCOLORATION AROUND THE OUTER HEMISPHERE OF THE EXPLANTED LINER, JUST BELOW THE DOUBLE CHANNELED LOCKING RING. HE STATED HE THOUGHT THIS WAS EVIDENCE OF SOME CORROSION AND HYPOTHESIZED IT MAY BE DUE TO THE INSTABILITY OF THE CONSTRUCT. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 12964823 ↗
• InjuryMar 30, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED SURGERY, IT WAS IMPOSSIBLE TO IMPACT THE 20 DEG XLPE ACET LNR 32MM X 60MM ON THE PATIENT CORRECTLY. TO SOLVE THIS, 36 POLYETHYLENE WAS PLACED, WHICH IMPACTED WITHOUT PROBLEM. THE PROCEDURE WAS COMPLETED WITH A LESS THAN OR EQUAL TO 30 MINS DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11587197 ↗
• InjuryNov 27, 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 DUE TO AN INFECTION. THE OXINIUM FEM HEAD AND R3 20 DEG XLP ACET LNR 32 MM X 60 MM WERE REVISED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10913466 ↗
• InjuryMay 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THR REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2017 WITH EXTREME PAIN, DIFFICULTY FOR WALKING, WEIGHT LOSS, LETHARGIA, AND ANAEMIA DIAGNOSIS, THE PATIENT EXPERIENCED UNEXPLAINED PAIN AND ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS THAT MADE NECESSARY A SECOND REVISION SURGERY ON (B)(6) 2020. ACCORDING TO THE REPORT CONTENTS, THE ACETABULAR CUP, MODULAR HEAD, ACETABULAR LINER WERE EXPLANTED AND REPLACED WITH SMITH AND NEPHEW DEVICES. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A FIRST THR REVISION SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM FEMORAL PROSTHESIS AND THAT REQUIRED A SECOND REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Pain

  MAUDE report 10082871 ↗

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.