TANDEM 71363057Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010481696), received between Jan 5, 2021 and Jan 6, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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.

• MalfunctionJan 6, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED BEFORE THE THR PROCEDURE THAT THE TRIALS WERE FLAKING AND IMPACTED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING A BACKUP FROM SMITH & NEPHEW. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11124131 ↗
• MalfunctionJan 5, 2021Flaked; Flaked

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION BEFORE A TKA IT WAS NOTICED THAT THE TANDEM UNI CONV TRIAL 0MM, +45MM, +47MM, +53MM AND +57MM WERE FLAKING AND IMPACTING STERILIZATION PROCESS. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH-NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11120176 ↗