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R3 71334940Recalls & reported problems

Smith & Nephew, Inc. · R3 20 DEGREE XLPE ACETABULAR LINER 22MM INNER DIAMETER X OUTER DIAMETER 40MM · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010598066), received between Mar 2, 2021 and Mar 2, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (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 16, 2026.

Most reported problems

Device problems

  • Material Deformation1
  • Material Discolored1
  • Scratched Material1
  • Unexpected Color1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 2, 2021Material Discolored; Material Deformation; Scratched Material; Unexpected Color; Material Discolored; Material Deformation; Scratched Material; Unexpected Color

    IT WAS REPORTED THAT, AN OXINIUM FEM HD 12/14 22 MM +0 AND AN 20 DEG XLPE ACET LNR 22MM X MM40 ARE DAMAGED. ACCORDING TO THE PICTURES ATTACHED, BOTH DEVICES SEEMED TO BE USED, PRESENT SCRATCHES, THE OXINIUM FEM HD 12/14 22 MM +0 IS DISCOLORED AND THE 20 DEG XLPE ACET LNR 22MM X MM40 IS DEFORMED. THESE PROBLEMS WERE DETECTED DURING PROCEDURE, AND PATIENT INJURY WAS REPORTED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11402709 ↗

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.

Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices

All Prosthesis, hip, semi-constrained, metal/polymer, cemented devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page