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TANDEM 71322051Recalls & reported problems

Smith & Nephew, Inc. · TANDEM BIPOLAR COBALT CHROME 51MM 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 03596010492500), received between Oct 31, 2017 and Dec 14, 2017 — 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 (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
  • Device Dislodged or Dislocated1

Patient problems

  • Injury1
  • Joint Dislocation1
  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryDec 14, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT WAS ADMITTED FOR INCREASED POPPING AND DRAINAGE IN JOINT. ON (B)(6) 2015, THE PATIENT UNDERWENT A CLOSED REDUCTION UNDER ANESTHESIA. ON (B)(6) 2015, THE PATIENT UNDERWENT A CLOSED REDUCTION UNDER ANESTHESIA. ON (B)(6) 2015, THE PATIENT UNDERWENT A HIP ASPIRATION. ON (B)(6) 2015, THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE CONSTRUCT DUE TO AN INFECTED UNSTABLE LEFT HIP.

    Patient problems: Joint Dislocation; Unspecified Infection

    MAUDE report 7119523 ↗
  • InjuryOct 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A FEW ITEMS WERE EXPLANTED DUE TO INFECTION.

    Patient problems: Injury

    MAUDE report 6992296 ↗

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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