TANDEM 71363046Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010481597), received between Sep 4, 2020 and Oct 14, 2022 — classified as 4 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2022Flaked; Flaked

  IT WAS REPORTED THAT SHRAPNEL AND SHEDDING METAL WAS FOUND INSIDE ONE (1) TANDEM TRL SHELL 46MM. THE ISSUE WAS NOTICED AFTER THE SURGERY, DURING SPD. SURGERY WAS PERFORMED, WITHOUT ANY DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15610764 ↗
• MalfunctionSep 13, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, A TANDEM TRL SHELL 46MM IS CHIPPED. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414103 ↗
• MalfunctionMar 8, 2021Break; Break

  IT WAS REPORTED THAT, AFTER SURGERY IT WAS NOTICED THAT THE INSIDE RING OF THE TANDEM TRIAL SHELL HEADS ((B)(4)) ARE BROKEN AND CANNOT BE PROPERLY CLEANED. INCIDENT OCCURRED AFTER THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431632 ↗
• MalfunctionSep 4, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING INSPECTION THE TANDEM TRL SHELL'S WERE FOUND WITHOUT THREADS. THESE ARE OLD STYLES THAT NEVER HAD THREADS. NO CASE RELATED, THEREFORE, NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10497159 ↗