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TANDEM 71324054Recalls & reported problems

Smith & Nephew, Inc. · TANDEM INTERNATIONAL BIPOLAR 54MM OUTER DIAMETER 28MM INNER DIAMETER · Class 2 · Implant

All models of TANDEM (58)

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 03596010494450), received between Mar 11, 2018 and Apr 12, 2021 — classified as 2 injuries.

3 other recalls cover devices cleared under the same FDA submission (K023743, K211176, K231448); 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

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Bone Fracture(s)1
  • Implant Pain1

Recent adverse event reports

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

  • InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED, THAT SEVENTEEN MONTHS AFTER A RIGHT HIP HEMIARTHROPLASTY HAD BEEN PERFORMED, A REVISION SURGERY TOOK PLACE, DUE TO THE PATIENT INCREASING GROIN PAIN AND AGE RELATED DEGENERATIVE CHANGES IN THE ACETABULUM. THE BIPOLAR HEAD WAS REMOVED AND NEW IMPLANTS WERE INSERTED. IT IS UNKNOWN THE PATIENT CURRENT HEALTH STATUS.

    Patient problems: Implant Pain

    MAUDE report 11648431 ↗
  • InjuryMar 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    STEM SUBSIDENCE OWING TO FRACTURE AT CALCAR AND GREATER TROCHANTER SURGEON DISSECTED DOWN TO HIP JOINT. DISLOCATED HIP. REMOVED STEM AND BIPOLAR HEAD AS ONE CONSTRUCT USING THE POLARSTEM REMOVAL TOOL PREPARED CANAL FOR ECHELON CEMENTED STEM CEMENTED SIZE 14 175MM ECHELON STEM STD COLLAR. TRIALED BIPOLAR HEAD AND HIP DEEMED STABLE. INSERTED DEFINITIVE BIPOLAR CONSTRUCT ONTO STEM. REDUCED HIP. REDUCED GT FRACTURE AND FIXATED WITH PERIPROSTHETIC PLATE

    Patient problems: Bone Fracture(s)

    MAUDE report 7329703 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023743, K211176, K231448. 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-0350-2017 · Aug 29, 2016 · Terminated
    TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051,
  • Z-0351-2017 · Aug 29, 2016 · Terminated
    TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 7132

Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices

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Sources and updates

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