TANDEM 71367900Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010481733), received between Jul 18, 2020 and Feb 3, 2022 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2022Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, A TANDEM UNI CONV TRL 0MM BROKE. NO PIECES FELL INTO PATIENT. DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446701 ↗
• MalfunctionDec 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE INSIDE SNAP RING OF A TANDEM UNI CONV TRL 0MM WAS BROKEN AND WOULD NOT STAY ON THE TRIAL NECK. INCIDENT OCCURRED OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITH A DELAY OF LESS THAN OR EQUAL TO 30 MINUTES, WITH THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13101513 ↗
• MalfunctionNov 22, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE INSIDE SNAP RING OF A TANDEM UNI CONV TRL 0MM WAS BROKEN AND WOULD NOT STAY ON THE TRIAL NECK. INCIDENT OCCURRED OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITH A DELAY OF LESS THAN OR EQUAL TO 30 MINUTES, WITH THE SAME DEVICE. PATIENT WAS INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12852041 ↗
• MalfunctionNov 1, 2021Break; Break

  IT WAS REPORTED THAT THR SURGERY A WHITE RING INSIDE OF TANDEM UNI CONV TRL 0MM WAS NOTICED BROKEN AND MISSING, THE PIECE COULDN'T BE FOUND. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12727631 ↗
• MalfunctionJul 7, 2021Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT A TANDEM UNIPOLAR CONVERSION TRIAL 0MM WAS OBSERVED TO BE WORN AND CRACKED. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132797 ↗
• MalfunctionMay 19, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE TANDEM UNI CONV TRL 0 MM WAS NOT LONGER ENGAGING TAPERS. IT IS UNKNOWN IF THIS WAS NOTICED DURING SURGERY OR NOT; THEREFORE, PATIENT INVOLVEMENT IS NOT CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850236 ↗
• 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 11124100 ↗
• 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 11119824 ↗
• InjuryJul 18, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING TOTAL HIP REPLACEMENT THE UNIPOLAR TRIAL HEADS DO NOT STAY ON THE STEM OR BROACH TRIALS. IT WAS TRIED ALL 5 DEVICES AND THE POP OFF NON STOP. A DELAY WAS REPORTED OF 10 MINUTES TO 15 MINUTES. THE PROCEDURE WAS FINISHED USING A CHANGE IN THE SURGICAL TECHNIQUE. A DIFFERENT DEVICE HAS TO BE USED TO FINISHED THE PROCEDURE. THE PROCEDURE WAS FINISHED USING 28 MM BIPOLAR HEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10293443 ↗