TANDEM 71324050Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010494412), received between Nov 3, 2020 and Nov 1, 2022 — classified as 4 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, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN HEMIARTHROPLASTY SURGERY, THE PATIENT EXPERIENCED AN INFECTED HIP. THIS ADVERSE EVENT WAS SOLVED/TREATED BY A TOTAL HIP REPLACEMENT REVISION SURGERY ON (B)(6) 2022. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 15711357 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN HEMIARTHROPLASTY, A REVISION SURGERY WAS PERFORMED TO EXCHANGE A TANDEM INTL BIPOLAR 50OD 28ID DUE TO INFECTION. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 15540204 ↗
• InjuryJul 29, 2022Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED A TANDEM INTL BIPOLAR 50OD 28ID ABNORMAL POSITION, AS IT MIGRATED HORIZONTALLY MAKING ALMOST IN DIRECT CONTACT WITH THE FEMORAL STEM. THIS WAS CONFIRMED UPON CONDUCTING POSTOPERATIVE X-RAYS RIGHT AFTER THE SURGERY WAS CONCLUDED. ON (B)(6) 2022, ADDITIONAL X-RAYS WERE TAKEN WHERE THE DISLOCATION OF THE BIPOLAR PROSTHESIS WAS EVIDENCED, AS THE FEMORAL HEAD COMPLETELY SEPARATED FROM THE TANDEM INTL BIPOLAR 50OD 28ID CONSTRUCT . THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2022. DURING THIS PROCEDURE, THE TANDEM INTL BIPOLAR 50OD 28ID WAS REMOVED AND EXCHANGED FOR AN IMPLANT OF ANOTHER COMPANY. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 15129321 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A HIP HEMIARTHROPLASTY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED TO EXCHANGE THE TANDEM INTL BIPOLAR 50OD 28ID LINER. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 10779954 ↗

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,