Tornier Flex Shoulder System DWF603ARecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03700434022599), received between Mar 1, 2022 and Oct 20, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Migration” (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. 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.

• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 23334444 ↗
• 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 21207741 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "STUDY: SHOUT SUBJECT: (B)(6). DIAGNOSED WITH ROTATOR CUFF DISEASE, DISCUSSED OBTAINING ULTRASOUND TO EVALUATE FOR ROTATOR CUFF TEAR. MEDICATION: STEROID INJECTION,1CC 40MG KENALOG AND 4CC NORMAL SALINE; PATIENT RECEIVED STEROID INJECTION IN THE RIGHT SHOULDER. SCHEDULED SURGERY FOR (B)(6) 2025"

  Patient problems: Muscle/Tendon Damage

  MAUDE report 20683142 ↗
• InjuryOct 17, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  AS REPORTED: "STUDY: SHOUT SUBJECT: (B)(6). INSTABILITY/DISLOCATION. PATIENT REQUIRED REVISION SURGERY."

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 20468789 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION".

  Patient problems: Unspecified Infection

  MAUDE report 19205334 ↗
• InjuryMar 20, 2024Off-Label Use; Detachment of Device or Device Component; Off-Label Use; Detachment of Device or Device Component

  THE PATIENT UNDERWENT A TOTAL LEFT SHOULDER REPLACEMENT AND LATER EXPERIENCED WEAKNESS IN THE LEFT SHOULDER. DIAGNOSTIC TESTS WERE CONDUCTED TO DETERMINE THE CAUSE. FOLLOWING CONSULTATION WITH A NEW PHYSICIAN, IT WAS DETERMINED THAT A NEW GLENOID HEAD WAS NEEDED. THE PATIENT IS SCHEDULED FOR REVISION SURGERY AT STANFORD HOSPITAL. ADDITIONALLY, THE SURGEON INFORMED THE PATIENT THAT IMPLANTED PARTS WILL NO LONGER BE PROVIDED TO PATIENTS. DESPITE THIS, THE PATIENT CONFIRMED THEIR SCHEDULED REVISION SURGERY. THE PATIENT IS REPORTING PAIN AS WELL AS WEAKNESS IN THE SHOULDER.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 18944231 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RE-OPERATION WITHOUT COMPONENT CHANGE DUE TO A PERIPROSTHETIC FRACTURE.

  Patient problems: Limb Fracture

  MAUDE report 18387156 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REVISION SURGERY WAS PLANNED USING THE BLUEPRINT PLANNING FEATURE. THE PRIMARY IMPLANTS USED WERE FROM STRYKER/TORNIER, SPECIFICALLY A FLEX HEMI IN. THE ORIGINAL IMPLANTS INCLUDED A FLEX 3 SHORT STEM AND A 43X16 HEAD, BOTH IMPLANTED IN 2016. THE REASON FOR THE REVISION SURGERY WAS A TORN SUBSCAPULARIS.

  Patient problems: Insufficient Information

  MAUDE report 18386474 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2019 A PATIENT REQUIRED REVISION SURGERY DUE STIFFNESS, EVENT WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Loss of Range of Motion

  MAUDE report 17599448 ↗
• InjuryMay 15, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6)2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON 09 AUGUST 2017 A PATIENT REQUIRED REVISION SURGERY DUE " CUFF INSUFFICIENCY/ASEPTIC LOOSENING", WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.REVISION PROCEDURE TYPE : "SINGLE STAGE REVISION¿

  Patient problems: Osteolysis

  MAUDE report 16931078 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THRU STUDY CONTROL THAT PATIENT DEVELOPED A HEMATOMA. RELATEDNESS TO THE STUDY AND SURGICAL PROCEDURE. NO SPECIFIC DEVICE IS NOTED AS CAUSE OF ISSUE. THE PATIENT UNDERWENT EVACUATION OF THE HEMATOMA WHICH INVOLVED SURGERY AND THREE DAYS IN THE HOSPITAL.

  Patient problems: Hematoma

  MAUDE report 15298339 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POST-OPERATIVE PAIN WHICH LIMITED THEIR RANGE OF MOTION. THROUGH CT SCANS IT WAS REVEALED THAT THE PATIENT HAD INFERIOR OSTEOPHYTE.

  Patient problems: Extraskeletal ossification; Implant Pain; Loss of Range of Motion

  MAUDE report 15285679 ↗
• InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT THERE WAS A DESCALING AND ACUTE SEPSIS OF THE PATIENT'S RIGHT SHOULDER.

  Patient problems: Bacterial Infection; Inadequate Osseointegration; Sepsis

  MAUDE report 15280108 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PAIN AND SHOULDER STIFFNESS AND UNDERWENT ARTHROSCOPIC ARTHROLYSIS REVISION.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 13635133 ↗
• 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 13634613 ↗