R3 71339556Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010615251), received between Aug 23, 2017 and Nov 15, 2022 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2018 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED A DISSOCIATION OF LINER THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2018. DURING THIS PROCEDURE, THE ACETABULAR LINER AND FEMORAL HEAD WERE EXPLANTED AND REPLACED WITH SMITH AND NEPHEW COMPONENTS. 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 PRIMARY THR SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 15798383 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED AN EARLY DISLOCATION. A REVISION SURGERY WAS REQUIRED TO ADDRESS THIS EVENT; THE R3 0 DEG XLPE ACET LNR 32 MM X 56 MM AND THE OXONIUM FEM HD 12/14 32 MM +4 WERE EXPLANTED. THE LINER WAS CHANGED TO A CONSTRAINED LINER. ACETABULAR CUP AND FEMORAL STEM WERE LEFT IN SITU. CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12497345 ↗
• InjuryAug 27, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT SUFFERED A SECOND DISLOCATION AFTER HIS RIGHT TOTAL HIP REPLACEMENT. THERE IS NOT ANY NOTIFICATION THAT A MEDICAL INTERVENTION OR TREATMENT WAS PERFORMED TO CORRECT THE PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7816131 ↗
• MalfunctionAug 27, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT SUFFERED A DISLOCATION THREE WEEKS AFTER HIS RIGHT TOTAL HIP REPLACEMENT. THERE IS NOT ANY NOTIFICATION THAT A MEDICAL INTERVENTION OR TREATMENT WAS PERFORMED TO CORRECT THE PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7816115 ↗
• InjuryAug 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO A PATIENT TO REPLACE THE LINER AND THE FEMORAL HEAD DUE TO CONTINUOUS DISLOCATIONS.

  Patient problems: Joint Dislocation

  MAUDE report 7803906 ↗
• InjuryJun 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING AND DISLOCATION OF THE CUP. THE ACETABULAR SHELL, THE LINER, THE FEMORAL HEAD AND THE HEAD SCREW WERE EXPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 7608423 ↗
• InjuryAug 23, 2017Unintended Movement; Insufficient Device Problem Information; Unintended Movement; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION HIP SURGERY WAS PERFORMED FOR UNSPECIFIED REASONS.

  Patient problems: Injury

  MAUDE report 6815431 ↗

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.