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R3 71337552Recalls & reported problems

Smith & Nephew, Inc. · R3 0 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 52MM · Class 2 · Implant

Data updated Oct 13, 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 03596010615206), received between May 19, 2021 and May 19, 2021 — 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

  • Joint Dislocation1

Recent adverse event reports

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

  • InjuryMay 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A HIP RECONSTRUCTION SURGERY HAD BEEN PERFORMED IN 2015, THE PATIENT EXPERIENCED RECURRENT DISLOCATION OF THE RIGHT HIP. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO ADDRESS THIS ADVERSE EVENT: THE OXINIUM FEM HD 12/14 32MM +0 WAS REMOVED WITH PUNCH AND MALLET, AND THE R3 0 DEG XLPE ACET LNR 28MM X 52MM WAS REMOVED FROM EXISTING CUP WITH R3 LINER REMOVAL TOOL. THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS PRE AND POST SURGERY. NO SPECIMENS WERE TAKEN FOR CULTURE AND SENSITIVITY. THE FOLLOW UP CONDITION OF PATIENT IS UNKNOWN AND NOT AVAILABLE.

    Patient problems: Joint Dislocation

    MAUDE report 11851857 ↗

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

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