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R3 71338552Recalls & reported problems

Smith & Nephew, Inc. · R3 20 DEGREE +4 XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM · Class 2 · Implant

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

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010598714), received between Sep 11, 2017 and Mar 7, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

  • Device Dislodged or Dislocated1
  • Insufficient Device Problem Information1

Patient problems

  • Injury2
  • Unspecified Infection1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO CHRONIC DISLOCATION OF TOTAL HIP. LINER COMPONENT EXPLANTED.

    Patient problems: Injury

    MAUDE report 8401316 ↗
  • InjurySep 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO AN INFECTION. THIS REQUIRED A CHANGE OF THE HEAD & LINER.

    Patient problems: Injury; Unspecified Infection

    MAUDE report 6855795 ↗

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-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.
  • 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.

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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