Tornier Flex Shoulder System DWF421CRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700434021561), received between Mar 1, 2022 and Aug 3, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 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.

• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that, originally revision surgery cancelled due to unknown reasons. It was rebooked for (b)(6)2026. Surgeon had planned to revise glenoid due to glenoid loosening during a recent fall. During case, surgeon identified that arthroplasty joint had been infected in his opinion. All humeral and glenoid components were removed without difficulty. Multiple tissue samples were taken. Debridement and copious lavage was performed. Antibiotic cement spacer was implanted for a two stage revision. Dr (b)(6) stated that there were no clinical markers indicative of joint infection. Second stage revision planned for 2-3 months. No further x-ray & CT available No pathology report available No other pt details available. Second stage procedure using competitor product.

  Patient problems: Unspecified Infection

  MAUDE report 50122405 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "EXPLANT RIGHT RSA WITH PLACEMENT OF ANTIBIOTIC CEMENT SPACER FOR INFECTION." THE SHOULDER HAD BEEN DRAINING PUSS FOR A LONG TIME.

  Patient problems: Unspecified Infection

  MAUDE report 21207740 ↗
• InjuryDec 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "PATIENT HAD DISLOCATED THEIR SHOULDER AND SO A REVISION SURGERY WAS PLANNED. SURGEON REMOVED THE TRAY AND POLY AND A NEW TRAY WAS PUT IN AND AN UPSIZED POLY. LEFT SIDE. NO ADVERSE CONSEQUENCES DURING THE REVISION SURGERY. THE PATIENT WAS AWARE THAT THEY HAD DISLOCATED THEIR SHOULDER AND AS SUCH NEEDED IT TO BE REVISED. THE INCIDENT WAS NOT IN RELATION TO ANY MALFUNCTION OF THE IMPLANTS/DEVICES. IT WAS REVISED DUE TO PATIENT DISLOCATING AND NEED A LARGER SIZED IMPLANT. IN THE IMAGE THE IMPLANT LOOKS BROKEN THAT IS ONLY BECAUSE IT WAS DAMAGED BY THE SURGEON DURING REMOVAL OF THE IMPLANT."

  Patient problems: Joint Dislocation

  MAUDE report 18263495 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTION AS A POST-OPERATIVE COMPLICATION. THE PATIENT REPORTS HAVING PAIN. THE PATIENT UNDERWENT A RE-OPERATION WITH COMPONENT CHANGE.

  Patient problems: Implant Pain; Post Operative Wound Infection

  MAUDE report 13634976 ↗