TANDEM 71363047Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010481603), received between Jan 5, 2021 and Jan 26, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 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 TANDEM TRL SHELL 47MM WAS NOTICED TO BE SCRATCHED AND CHIPPED. NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13354048 ↗
• MalfunctionMay 4, 2021Material Deformation; Scratched Material; Material Deformation; Scratched Material

  IT WAS REPORTED THAT TANDEM TRL SHELL 43MM, TANDEM TRL SHELL 44MM, TANDEM TRL SHELL 45MM, AND TANDEM TRL SHELL 47MM HAD SCRATCHES AND GOUGES. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773489 ↗
• 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 11431642 ↗
• 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 11124110 ↗
• 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 11120099 ↗