Tornier Flex Shoulder System DWF425CRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700434022445), received between Mar 29, 2024 and Nov 28, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT (B)(4) SHOUT - TORNIER SHOULDER OUTCOMES STUDY. SHOULDER PAIN SUBJECT IS EXPERIENCING DISCOMFORT IN THE SHOULDER. PER CALL WITH SITE ON 31-OCT-2024, VERBALLY REVIEWED ADDITIONAL CLINIC NOTES: ON (B)(6) 2023, NO CHANGE RADIOGRAPHICALLY (ONGOING), ON (B)(6) 2024 WORSENING PAIN, NO LOOSENING AND NO CHANGE IN ALLOGRAFT, LUCENCY AROUND BASEPLATE, BUT NO SHIFTING OF POSITION (ONGOING)".

  Patient problems: Discomfort; Implant Pain

  MAUDE report 20804609 ↗
• InjuryMar 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT DISLOCATED THEIR SHOULDER AND UNDERWENT SURGERY AFTER A WAITING PERIOD. DURING THE SURGERY, A PIECE OF BONE CAUSING THE DISLOCATION WAS SANDED DOWN. THE PATIENT WORE A SLING THROUGHOUT THE RECOVERY PERIOD BUT DID NOT RECEIVE ANY PHYSICAL THERAPY.

  Patient problems: Joint Dislocation

  MAUDE report 19005650 ↗
• InjuryMar 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT EXPERIENCED ANOTHER SHOULDER DISLOCATION WHILE STILL RECOVERING FROM SURGERY INTENDED TO ADDRESS A PREVIOUS DISLOCATION. FOLLOWING THE RECENT DISLOCATION, THE PATIENT REMAINED IN A SLING FOR A WEEK OR TWO. IN RESPONSE, MEDICAL INTERVENTION INVOLVED LOCATING THE ROTATOR CUFF MUSCLE AND REPOSITIONING IT IN AN ATTEMPT TO ADDRESS THE UNDERLYING CAUSE OF THE DISLOCATION. NOTABLY, THE PREVIOUSLY INSERTED STEM WAS NOT REMOVED DURING THIS PROCEDURE.

  Patient problems: Joint Dislocation

  MAUDE report 19005250 ↗
• InjuryMar 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT EXPERIENCED ANOTHER SHOULDER DISLOCATION. X-RAYS SHOWED NO SIGNIFICANT ISSUES, AND THE SURGEON APPROVED THE PATIENT FOR PHYSICAL THERAPY. THE PATIENT BEGAN PHYSICAL THERAPY, WEARING A SLING IN CROWDED AREAS BUT OTHERWISE USING THE ARM AS DIRECTED BY THE PHYSICIAN. THE SURGEON INSERTED A LARGER ROUND PIECE, A STEM, AND A PLASTIC DISC TO FILL THE GAP IN THE SHOULDER. THE SURGEON DISCUSSED THE POSSIBILITY OF TRANSITIONING FROM A REVERSE SHOULDER ARTHROPLASTY (RSA) TO A REGULAR SHOULDER, OR ALTERNATIVELY, FOR THE PATIENT TO CONSIDER LIVING WITH LIMITED SHOULDER FUNCTION, AS FULL USE MAY NOT BE ACHIEVABLE.

  Patient problems: Joint Dislocation

  MAUDE report 19005202 ↗