TANDEM 71367912Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010481771), received between Nov 19, 2021 and Jan 10, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjuryJan 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, AFTER A THR SURGERY, THE TANDEM UNI CONV TRL +12MM CAME OFF INSIDE OF THE PATIENT'S PELVIS. THE TRIAL HEAD WAS DAMAGED WHILE BEING REMOVED FROM THE PELVIS. THE SURGERY HAD BEEN COMPLETED, WITHOUT ANY DELAY. THE PROCEDURE WAS FINISHED WITH THE SAME INSTRUMENT. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13212194 ↗
• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE INSIDE SNAP RING OF A TANDEM UNI CONV TRL +12MM WAS BROKEN AND WOULD NOT STAY ON THE TRIAL NECK. INCIDENT OCCURRED OUTSIDE PATIENT. SURGERY WAS PERFORMED WITH THE SAME DEVICE, WITH LESS THAN 30 MINUTES OF SURGICAL DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12844925 ↗