TANDEM 71367903Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010481740), received between Jul 18, 2020 and Jan 26, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2022Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT A TWO TANDEM UNI CONV TRL -3MM WERE NOTICED TO BE SCRATCHED AND CHIPPED. NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13353992 ↗
• MalfunctionDec 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE INSIDE SNAP RING OF A TANDEM UNI CONV TRL -3MM 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 13101551 ↗
• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE INSIDE SNAP RING OF A TANDEM UNI CONV TRL -3MM 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 INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12848675 ↗
• 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: Failure of Implant; No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10293445 ↗
• InjuryJul 18, 2020Protective Measures Problem; Protective Measures 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 Consequences Or Impact To Patient

  MAUDE report 10293052 ↗