TANDEM 71322042Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010492418), received between Feb 16, 2021 and Feb 16, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A TKA, THE GII C/R ART INS SZ 1-2 11MM WAS NOT LOCKING PROPERLY. THE INSERT WAS REMOVED AND A NEW INSERT WAS OPENED BUT THAT INSERT ALSO NOT LOCKING PROPERLY. PROCEDURE FINISHED WITH BACKUP DEVICE. DELAY GREATER THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11332961 ↗
• MalfunctionFeb 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A HIP HEMIARTHROPLASTY, WHEN REDUCTING THE HIP, WITH ALL IMPLANTS IN PLACE, THE COCR 12/14 FEM HEAD 22 + 0 DISASSOCIATE FROM THE TANDEM BIPOLAR COCR 42OD 22ID AND STAYED ON THE STEM. SURGEON REMOVED HEAD FROM STEM AND PUT THOSE IMPLANTS BACK TOGETHER AND TRIED AGAIN, BUT IT HAPPENED AGAIN. ON THE SECOND TIME OF TRYING TO REMOVE THE HEAD FROM THE STEM, THE WHOLE STEM CAME OUT. SURGEON HAD TO PLACE NEW STEM AND NEW TANDEM IMPLANTS. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MIN USING A SMITH-NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11332959 ↗
• MalfunctionFeb 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A HIP HEMIARTHROPLASTY, WHEN REDUCTING THE HIP, WITH ALL IMPLANTS IN PLACE, THE COCR 12/14 FEM HEAD 22 + 0 DISASSOCIATE FROM THE TANDEM BIPOLAR COCR 42OD 22ID AND STAYED ON THE STEM. SURGEON REMOVED HEAD FROM STEM AND PUT THOSE IMPLANTS BACK TOGETHER AND TRIED AGAIN, BUT IT HAPPENED AGAIN. ON THE SECOND TIME OF TRYING TO REMOVE THE HEAD FROM THE STEM, THE WHOLE STEM CAME OUT. SURGEON HAD TO PLACE NEW STEM AND NEW TANDEM IMPLANTS. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30MIN USING A SMITH-NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11332950 ↗

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,