TANDEM 71324040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010494313), received between Apr 11, 2020 and Mar 21, 2023 — classified as 1 injury, 1 malfunction.

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, 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

Recent adverse event reports

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

• InjuryMar 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT DISLOCATED THE HIP JOINT DUE TO IMPROPER MOVEMENT 7 DAYS LATER, AND THE ACETABULAR CUP FELL OFF DURING THE REDUCTION PROCESS. THIS ADVERSE EVENT WAS SOLVED TROUGH A REVISION SURGERY PERFORMED ON (B)(6) 2023 IN WHICH THE FEMORAL HEAD AND ACETABULAR COMPONENT WERE EXPLANTED AND CHANGED. PATIENT CURRENT HEALTH STATUS IS STABLE

  Patient problems: Joint Dislocation; Pain

  MAUDE report 16587418 ↗
• MalfunctionApr 11, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A SURGERY, AFTER THE PROSTHESIS WAS INSTALLED, IT WAS FOUND THAT THE CLASP FELL OFF. AFTER REPEATED INSTALLATION AND REPLACE, THE CLASP STILL FELL OFF. FINALLY A BIGGER SIZE BIPOLAR WAS USED TO COMPLETE THE SURGERY. IT IS UNKNOWN IF THERE WAS A DELAY. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9951743 ↗

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-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,