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TANDEM 71322052Recalls & reported problems

Smith & Nephew, Inc. · TANDEM BIPOLAR COBALT CHROME 52MM 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 03596010492517), received between Dec 28, 2018 and Jun 24, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Defective Device” (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

  • Defective Device1
  • Device Dislodged or Dislocated1

Patient problems

  • Injury1
  • No Information1

Recent adverse event reports

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

  • InjuryJun 24, 2020Defective Device; Defective Device

    IT WAS REPORTED THAT, AFTER A THA SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. A REVISION SURGERY WAS PERFORMED IN WHICH THE TANDEM BIPOLAR SHELL/LINER WAS EXCHANGED. THE PATIENT OUTCOME IS UNKNOWN.

    Patient problems: No Information

    MAUDE report 10188200 ↗
  • InjuryDec 28, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A TANDEM SHELL DISLOCATED FROM THE STEM WITHOUT THE HEAD COMING OFF THE STEM. RETAINING RING IS REPORTED TO BE STUCK IN THE SHELL AND COULD NOT BE REMOVED. STEM REMAINED IN THE PATIENT.

    Patient problems: Injury

    MAUDE report 8205001 ↗

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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