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TANDEM 71322045Recalls & reported problems

Smith & Nephew, Inc. · TANDEM BIPOLAR COBALT CHROME 45MM 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 03596010492449), received between Aug 14, 2018 and May 12, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K023743); 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 Problem1
  • Unintended Movement1

Patient problems

  • Joint Dislocation2

Recent adverse event reports

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

  • InjuryMay 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A THR REPLACEMENT HAD BEEN PERFORMED, THE PATIENT FELL AT SOME POINT. WHEN THE SURGEON TRIED TO REDUCE THE DISLOCATION OF THE PATIENT, THE TANDEM BIPOLAR IMPLANT FAILED. THEN, A REVISION SURGERY WAS PERFORM TO EXPLANT THE DEVICE. THE PATIENT OUTCOME IS UNKNOWN.

    Patient problems: Joint Dislocation

    MAUDE report 10045902 ↗
  • InjuryAug 14, 2018Unintended Movement; Unintended Movement

    IT WAS REPORTED THAT THE SURGEON HAD A PATIENT RETURN FOR A PREVIOUSLY IMPLANTED, DISLOCATED HEMI BIPOLAR. THE 28MM COCR HEAD REMAINED ON THE SYNERGY STEM TRUNION UPON DISLOCATION, YET THE SHELL AND POLY RING DID NOT DISENGAGE. THE POLY RING REMAINED INTACT WITH THE SHELL WHILE THE HEAD DISLODGED ITSELF FROM THE SHELL. A SIMILAR SIZED SHELL WAS THEN OPENED AND A NEW HEAD WAS UPSIZED TO A 28MM +4 COCR HEAD.

    Patient problems: Joint Dislocation

    MAUDE report 7781459 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023743. 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-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
  • 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,

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

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

Sources and updates

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