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R3 71337550Recalls & reported problems

Smith & Nephew, Inc. · R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 50MM · Class 2 · Implant

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 03596010615190), received between Feb 28, 2022 and Feb 28, 2022 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Swelling/ Edema1

Recent adverse event reports

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

  • InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A THR ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 DUE TO ACCUMULATING WATER. THE R3 0 DEG XLPE ACET LNR 28MM X 50MM WAS EXPLANTED. THE SURGEON SAYS IT WAS NOT CAUSED BY INFECTION. NO CAUSATIVE MICROORGANISM (BACTERIA) IS DETECTED. ALSO, THE SURGEON DID NOT THINK S+N DEVICES WERE DEFECTIVE. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF THE PATIENT.

    Patient problems: Swelling/ Edema

    MAUDE report 13619386 ↗

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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.