Tornier Flex Shoulder System DWF500Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03700434022155), received between May 24, 2023 and Jul 30, 2025 — classified as 15 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). REVIVE HRS STUDY. PATIENT SEEN FOR SWELLING AND PAIN OF RIGHT SHOULDER (OPERATED SHOULDER) ACCORDING TO THE SURGEON, THIS EVENT IS NOT RELATED TO THE DEVICE OR THE SURGERY.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 22663553 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REVISION SURGERY WAS PERFORMED DUE TO ALLEGED PATIENT PAIN AND SUPERIOR MIGRATION OF THE GLENOID IMPLANTS.

  Patient problems: Pain

  MAUDE report 22375671 ↗
• InjuryJan 15, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  A REVISION SURGERY WAS PLANNED TO BE PERFORMED ON (B)(6)2024, USING THE BLUEPRINT PLANNING FEATURE. THE PATIENT WAS REVISED DUE TO REPORTED DISLOCATION AND PAIN.

  Patient problems: Implant Pain

  MAUDE report 21163836 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6). SHOUT - TORNIER SHOULDER OUTCOMES STUDY. CONSIDERABLE ONGOING LEFT SHOULDER PAIN AND INCREASING LEFT AXILLARY PAIN. NO INJURY. ON (B)(6) 2021, SUBJECT FIRST REPORTED CONSIDERABLE LEFT SHOULDER PAIN. X-RAYS AND PHYSICAL EXAM WERE NORMAL WITHOUT ANY EVIDENCE OF COMPLICATION. HE WAS INSTRUCTED TO RETURN IN 1 YEAR FOR ANNUAL FOLLOW UP. ON (B)(6) 2022, HE REPEATED THESE COMPLAINTS. YET AGAIN, X-RAYS DID NOT REVEAL EVIDENCE OF LOOSENING. SURGEON ATTEMPTED ASPIRATION TO SEND FOR CULTURE, BUT WAS UNABLE TO OBTAIN ANY FLUID. SUBJECT WAS SENT FOR CBC, ESR, AND CRP LABS. SURGEON THOUGHT INFECTION WAS UNLIKELY, BUT WANTED TO INVESTIGATE ALL POTENTIAL CAUSES FOR ONGOING PAIN. ON (B)(6) 2022, SUBJECT RETURNED WITH CONTINUED COMPLAINTS OF PAIN, ESPECIALLY AROUND THE PECTORALIS INSERTION AND TO A LESSER DEGREE IN THE BACK OF THE SHOULDER. HE COMPLAINED OF SOME MECHANICAL SYMPTOMS ESPECIALLY AT NIGHTTIME, WHEN HE IS POSITIONED IN BED, AND WITH MOTION. INFLAMMATORY LAB WORKUP WAS NEGATIVE. DR. (B)(6) SUGGESTED CT SCAN TO RULE OUT MECHANICAL COMPLICATIONS. ON (B)(6) 2022, SUBJECT RETURNED FOR CT REVIEW, WHICH DID NOT SHOW ANY MECHANICAL COMPLICATIONS. SURGEON STATED THA

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 21122538 ↗
• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT 008-00042 SHOUT - TORNIER SHOULDER OUTCOMES STUDY PAIN IN THE SHOULDER DUE TO A FALL."

  Patient problems: Fall; Implant Pain

  MAUDE report 21045856 ↗
• InjuryNov 28, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  AS REPORTED: "SUBJECT (B)(6) SHOUT - TORNIER SHOULDER OUTCOMES STUDY. RECENTLY UNDERWENT REVISION REVERSE WITH AN ALLOGRAFT PROSTHESIS AND SUBSEQUENTLY HAD A DISLOCATION. ON (B)(6) 2022: INSERT, TRAY AND GLENOSPHERE WERE REPLACED DURING REVISION SURGERY DUE TO INSTABILITY- DISLOCATION. INSERT: 39 DIA RETENTIVE +9MM/7.5C, TRAY: CENTERED +0MM, GLENOSPHERE: 39MM LATERALIZED (+3MM)."

  Patient problems: Joint Laxity; Subluxation

  MAUDE report 20804611 ↗
• InjuryNov 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT 008-00073 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: ¿ (B)(6) 2023, NO CHANGE RADIOGRAPHICALLY (ONGOING), ¿ (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 20804607 ↗
• InjuryNov 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT (B)(6) SHOUT - TORNIER SHOULDER OUTCOMES STUDY. LEFT SHOULDER PAIN. SUBJECT EXPERIENCED INCREASED PAIN IN SHOULDER. THE CT SHOWED EARLY LOOSENING OF THE CENTRAL SCREW ON THE BASEPLATE. 2 STAGE-REVISION SURGERY: (B)(6) 2022: SUBJECT UNDERWENT RESECTION ARTHROPLASTY WITH PLACEMENT OF ANTIBIOTIC SPACER (1ST STAGE REVISION). (B)(6) 2022: IMPLANTATION OF REVIVE DUE TO SUBJECT EXPERIENCED INCREASED PAIN IN SHOULDER. THE CT SHOWED EARLY LOOSENING OF THE CENTRAL SCREW ON THE BASEPLATE (2ND STAGE REVISION)."

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 20804530 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO DISCOMFORT.

  Patient problems: Discomfort

  MAUDE report 20508212 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT: (B)(6) - FLEX REVIVE STUDY. ADVERSE EVENT DETAIL: POST-OPERATIVE COMPLICATION: INCREASED PAIN AND STIFFNESS OF RIGHT SHOULDER. PATIENT HAS NO REDNESS OR SWELLING. ABNORMAL LABS(B)(6)2024: CRP, ESR, CBC(HGB, HCT, RDW) AS WELL AS UNDERLYING DEGENERATIVE DISK DISEASE OF THE CERVICAL SPINE. TREATMENT/MEDICATION: PREDNISONE 5MG FOR 15 DAYS.

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 19985975 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A LAWSUIT THAT THE PATIENT REPORTED HAVING REFRACTORY PAIN AND DYSFUNCTION OF THE SHOULDER WHICH WAS REFRACTORY TO CONSERVATIVE MEASURES. PREOPERATIVE IMAGING WAS SUGGESTIVE OF LOOSENING OF THE HUMERAL COMPONENT, SPECIFICALLY AT THE JUNCTION OF THE PROXIMAL HUMERAL BODY TO THE HUMERAL STEM AT THE ASSEMBLY SCREW JUNCTION.

  Patient problems: Implant Pain

  MAUDE report 17905768 ↗
• InjurySep 18, 2023Migration; Migration

  IN THE TORNIER SHOULDER OUTCOMES STUDY, A RADIOGRAPH REPORT NOTED A NOTCH EXTENDING TO A LOWER SCREW. THE ISSUE WAS MANAGED WITH CONSERVATIVE CARE. THERE HAVE BEEN NO ADDITIONAL FOLLOW-UP VISITS FOR THIS PATIENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17770463 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN THE CASE OF THE SHOUT SUBJECT, AN ACROMIAL FRACTURE WAS OBSERVED POSTOPERATIVELY, EVEN THOUGH IT WAS NOT PRESENT BEFORE THE SURGERY. THE SUBJECT REPORTED EXPERIENCING PAIN RADIATING FROM THE LATERAL ASPECT OF THE ARM INTO THE NECK AND THE BACK OF THE SCAPULA. A CT SCAN CONFIRMED THE PRESENCE OF AN ACROMIAL STRESS FRACTURE. THE ISSUE WAS ULTIMATELY RESOLVED WITH SEQUELAE.

  Patient problems: Bone Fracture(s); Implant Pain

  MAUDE report 17760770 ↗
• InjuryJun 26, 2023Device Dislodged or Dislocated; Osseointegration Problem; Device Dislodged or Dislocated; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE OF STEM, METAPHYSIS AND INSERT DUE TO HUMERAL REVIVE PROSTHESIS DISSOCIATION AND POSSIBLE SCREW LOOSENING. GLENOID BASEPLATE AND GLENOSPHERE WERE RETAINED FROM PRIOR PROCEDURE. ASSESSED AS DEFINITELY RELATED TO THE STUDY DEVICE, AND POSSIBLY RELATED TO THE SURGICAL PROCEDURE BY THE INVESTIGATOR.

  Patient problems: Joint Dislocation; Osteolysis

  MAUDE report 17200178 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE REV II BASEPLATE, SCREWS, AND GLENOSPHERE WERE REMOVED BECAUSE OF NOTCHING AND LOOSENING.

  Patient problems: Bone Shedding Debris; Inadequate Osseointegration

  MAUDE report 16997513 ↗