TANDEM 71367908Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010481764), received between Jul 18, 2020 and Mar 15, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) TANDEM UNI CONV TRL +8MM CRACKED AND BROKE IN TWO PIECES DUE TO EXCESSIVE WEAR AND TEAR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18913443 ↗
• MalfunctionDec 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE INSIDE SNAP RING OF A TANDEM UNI CONV TRL +8MM WAS BROKEN AND WOULD NOT STAY ON THE TRIAL NECK. INCIDENT OCCURRED OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITH A DELAY OF LESS THAN OR EQUAL TO 30 MINUTES, WITH THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13101658 ↗
• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE INSIDE SNAP RING OF A TANDEM UNI CONV TRL +8MM WAS BROKEN AND WOULD NOT STAY ON THE TRIAL NECK. INCIDENT OCCURRED OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITH A DELAY OF LESS THAN OR EQUAL TO 30 MINUTES, WITH THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12844866 ↗
• InjuryJul 18, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING TOTAL HIP REPLACEMENT THE UNIPOLAR TRIAL HEADS DO NOT STAY ON THE STEM OR BROACH TRIALS. IT WAS TRIED ALL 5 DEVICES AND THE POP OFF NON STOP. A DELAY WAS REPORTED OF 10 MINUTES TO 15 MINUTES. THE PROCEDURE WAS FINISHED USING A CHANGE IN THE SURGICAL TECHNIQUE. A DIFFERENT DEVICE HAS TO BE USED TO FINISHED THE PROCEDURE. THE PROCEDURE WAS FINISHED USING 28 MM BIPOLAR HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10293440 ↗