TANDEM 71324045Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010494368), received between Feb 2, 2018 and Aug 9, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A HIP ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED A DISASSOCIATION OF THE FEMORAL HEAD FROM THE BIPOLAR SHELL AS A CONSEQUENCE OF A FALL. THIS ADVERSE EVENT WAS SOLVED BY A REVISION PROCEDURE ON (B)(6) 2021 IN WHICH BOTH DEVICES WHERE REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12294342 ↗
• InjuryJul 29, 2021Connection Problem; Device Dislodged or Dislocated; Misassembly by Users; Connection Problem; Device Dislodged or Dislocated; Misassembly by Users

  IT WAS REPORTED THAT, AFTER A HIP HEMIARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021, THE HIP LUXATED THE NEXT DAY: THE TANDEM COMPONENT DISSOCIATED FROM THE HEAD. THE SURGEON HAD A HARD TIME TO CLICK THE RING OF THE TANDEM INTL BIPOLAR 45OD 28ID INTO THE HEAD UPON IMPLANTATION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021 TO EXPLANT BOTH TANDEM AND HEAD IMPLANTS.

  Patient problems: Joint Dislocation

  MAUDE report 12243755 ↗
• InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED.

  Patient problems: Failure of Implant; Injury

  MAUDE report 8002240 ↗
• InjuryJul 27, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AFTER THE BIPOLAR SURGERY, THE HEAD WAS REMOVED FROM THE BIPOLAR CUP WHILE THE PATIENT WAS MOVED ON A WHEELCHAIR. THREE DAYS LATER A REVISION SURGERY WAS PERFORMED.

  Patient problems: Joint Dislocation

  MAUDE report 7727140 ↗
• InjuryFeb 2, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO DISLOCATION. THE TANDEM SHELL AND THE FEMORAL HEAD WERE REMOVED.

  Patient problems: Injury

  MAUDE report 7237897 ↗

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-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,
• 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