TANDEM 71363053Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010481665), received between Jan 5, 2021 and Mar 8, 2021 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 11431634 ↗
• 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 11124122 ↗
• 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 11120116 ↗