Tornier Flex Shoulder System DWF520Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 03700434019100), received between Jan 10, 2022 and Sep 17, 2026 — classified as 66 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (14 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 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse 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  The manufacturer received a report from the National Joint Registry that contains unpublished collected data on the usage and the outcomes of the shoulder joint replacement.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 Aug 2026.During the review of the report, it was identified that on (b)(6) 2026 a patient required revision surgery due to infection & lysis- glenoid, which was not previously reported to the manufacturer.

  Patient problems: Unspecified Infection

  MAUDE report 50803902 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  A revision surgery was performed due to infection.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50054850 ↗
• InjuryJul 9, 2026Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  DURING MONTHLY FOLLOW-UP, IT HAS BEEN OBSERVED THAT THE POSITION OF THE TORNIER FLEX TRAY CHANGES, APPEARING AS IF THE TRAY IS NOT FIXED AND IS ROTATING.

  Patient problems: Joint Dislocation; Joint Laxity; Pain

  MAUDE report 25765012 ↗
• InjuryMar 30, 2026Device Dislodged or Dislocated

  THE PHYSICIAN REVISED STRYKER TORNIER FLEX REVERSE TRAY AND LINER AFTER PATIENT DISLOCATED. THE SURGEON TOOK OUT THE 39,+6 CONSTRAINED LINER AND HIGH OFFSET +0 TRAY AND REPLACED WITH A 39,+9 CONSTRAINED LINER AND CENTERED OFFSET +6 TRAY.

  Patient problems: Joint Dislocation

  MAUDE report 24730057 ↗
• InjuryMar 5, 2026Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 NOV. 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING HUMERUS, IMPINGEMENT AND UNEXPLAINED PAIN WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Impingement; Joint Laxity; Pain

  MAUDE report 24518564 ↗
• InjuryFeb 16, 2026Adverse 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) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 24342208 ↗
• InjuryJan 28, 2026Adverse 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 JULY 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, PERIPROSTHETIC FRACTURE & LYSIS- HUMERUS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s); Osteolysis; Unspecified Infection

  MAUDE report 24197667 ↗
• InjuryJan 28, 2026Adverse 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) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2021, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 24197592 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT LEFT REVERSE SHOULDER REPLACEMENT ON (B)(6) 2025. PT EXPERIENCED A VERY POSITIVE POST-OP REHAB / RECOVERY, DEMONSTRATING (ACCORDING TO THE SURGEON) A FULL RANGE OF MOTION OF HIS PROSTHETIC SHOULDER JOINT, WITHIN 6 WEEKS POST-OP. LATER, PATIENT WAS RIDING A PUSH BIKE (IN THE EARLY HOURS OF THE MORNING), AND FELL OFF, DISLOCATING HIS LEFT SHOULDER JOINT. UNABLE TO BE CLOSED REDUCED. SURGEON DECIDED ON A MUA, BOOKED FOR (B)(6) 2025. JOINT REDUCED, UNDER ANESTHESIA, BUT GROSSLY UNSTABLE. SURGEON DECIDED ON AN OPEN PROCEDURE. TORNIER FLEX REVERSED 0MM TRAY WAS REMOVED, ALONG WITH THE TORNIER REVERSED INSERT 39MM/9MM, AND A THICKER TRAY (6MM) AND (SAME SIZE) NEW INSERT WERE IMPLANTED. ON REDUCTION, THE JOINT WAS STILL UNSTABLE. SURGEON DISLOCATED THE JOINT, REMOVED THE NEW REVERSE TRAY / POLY INSERT, AND PROCEEDED TO EXPLORE FOR FURTHER CAUSES OF THE IMPINGEMENT / INSTABILITY. MORE POSTERO-INFERIOR GLENOID BONE WAS REMOVED. THE (PRIMARY) IMPLANTED 39MM STANDARD GLENOSPHERE WAS THEN REMOVED, REPLACED BY A 42MM STANDARD GLENOSPHERE. THE SUPERIOR GLENOID 30MM SCREW WAS FOUND TO BE LOOSE AND REPLACED WITH A 34MM SCREW. A NEW 12MM FLEX REVERSE TRAY

  Patient problems: Fall; Subluxation

  MAUDE report 24066669 ↗
• 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 23334526 ↗
• InjurySep 9, 2025Unstable; Unstable

  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 INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 23001736 ↗
• InjuryAug 8, 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 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 22747634 ↗
• InjuryAug 7, 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 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 22735485 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REVERSE SHOULDER ARTHROPLASTY WAS DONE FOR INFECTION. THE SURGEON MENTIONED ENTEROCOCCI WAS DETECTED. THE IMPLANTS WERE REMOVED AND CEMENT SPACER WAS IMPLANTED. NO PRODUCT FAULT WAS REPORTED.

  Patient problems: Bacterial Infection

  MAUDE report 22153892 ↗
• InjuryMay 23, 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 WITH THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED UNTIL (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2020, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 22078588 ↗
• InjuryMay 15, 2025Migration; Migration

  PATIENT UNDERWENT RIGHT REVERSE SHOULDER REPLACEMENT ON (B)(6) 2025. OVER RECENT WEEKS, PATIENT HAS DISLOCATED THEIR PROSTHETIC SHOULDER JOINT TWICE, DURING ABDUCTION AND EXTERNAL ROTATION. PATIENT UNDERWENT SHOULDER CT, AND REVIEWED BY SURGEON, WHO SUSPECTED SOME BONEY OR SOFT TISSUE IMPINGEMENT WAS CAUSING THE JOINT INSTABILITY, THOUGH CT LOOKED UNREMARKABLE. DURING SURGERY THERE WERE SOME BONEY PROJECTIONS ON THE POSTERIOR HUMERAL HEAD FOUND, & SUBSEQUENTLY REMOVED, PLUS SOME EXCESS POSTERIOR CAPSULE, ALSO REMOVED. JOINT LAXITY ALSO NOTED. THE PRIMARY POLY ,OFFSET TRAY REMOVED; PRIMARY IMPLANTED PERFORM REVERSE GLENOSPHERE REMOVED, AND REPLACED BY ECCENTRIC GLENOSPHERE. SURGEON ALSO IMPLANTED A TRAY AND POL. JOINT WAS FOUND TO BE STABLE, FULL RANGE OF MOTION DEMONSTRATED WITHOUT DISLOCATION. WOUND CLOSED.

  Patient problems: Joint Dislocation; Joint Impingement; Joint Laxity

  MAUDE report 22028023 ↗
• InjuryApr 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Dislocation; Subluxation

  MAUDE report 21882475 ↗
• 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 21207737 ↗
• InjuryDec 31, 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 PATIENT REPORTS PAIN AND SWELLING."

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 21045852 ↗
• InjuryDec 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR THE UPCOMING REVISION SURGERY. THE REASON FOR THE REVISION IS UNSPECIFIED TRAUMA.

  Patient problems: Insufficient Information

  MAUDE report 21036828 ↗
• InjuryOct 17, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  AS REPORTED: "STUDY: SHOUT SUBJECT: 101-00039-1REV. INSTABILITY/DISLOCATION. PATIENT REQUIRED REVISION SURGERY."

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 20468786 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6) INFECTION. PATIENT REQUIRED IRRIGATION AND DEBRIDEMENT ALONG WITH ANTIBIOTICS."

  Patient problems: Bacterial Infection

  MAUDE report 20349590 ↗
• InjurySep 25, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  AS REPORTED: "STUDY: SHOUT SUBJECT: (B)(6). POST-OPERATIVE AE: : INSTABILITY ¿ DISLOCATION SUBJECT LIFTED LARGE WATER BOTTLE ON (B)(6) 2024 AND FELT A POP. IMAGING SHOWED DISLOCATED RSA. PATIENT REQUIRED REVISION SURGERY. RE-OPERATION WITH COMPONENT CHANGE ON (B)(6) 2024."

  Patient problems: Joint Laxity; Subluxation

  MAUDE report 20298706 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF HUMERAL COMPONENTS DUE TO PERIPROSTHETIC FRACTURE CAUSE BY PATIENT FALL. THE HUMERAL COMPONENTS WERE REMOVED, AND REPLACED WITH A AEQUALIS FLEX REVIVE STEM, THE FRACTURE REDUCED TO THIS REVISION STEM. NO ISSUE WITH IMPLANTS.

  Patient problems: Fall; Limb Fracture

  MAUDE report 20292681 ↗
• InjuryAug 22, 2024Adverse 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)2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2019 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: DEBRIDEMENT AND IMPLANT RETENTION (DAIR).

  Patient problems: Unspecified Infection

  MAUDE report 20039476 ↗