Tornier Flex Shoulder System DWF421BRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 03700434021516), received between Feb 9, 2022 and Sep 18, 2026 — classified as 32 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Device Dislodged or Dislocated

  Patient problems: Osteolysis; Subluxation

  MAUDE report 50819505 ↗
• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  As reported: "Revision surgery due to infection. Primary surgery completed (b)(6)2024. All implants removed today due to infection. Wash out was attempted two weeks prior but failed."

  Patient problems: Medical device site infection

  MAUDE report 50193691 ↗
• InjuryMay 20, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 PROVIDED IN MONTHLY REPORT OF (B)(6) 2026. DURING THE REVIEW OF THE REPORT, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 25229463 ↗
• InjuryMay 20, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 FOR THE MONTHLY REPORT OF (B)(6) 2026 DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2026, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 25229278 ↗
• InjuryMar 25, 2026Unstable

  IT WAS REPORTED THAT, THE REVERSE SHOULDER REPLACEMENT WAS DONE FOR INSTABILITY. REVISION SURGERY FOR A POLY EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Joint Laxity

  MAUDE report 24688568 ↗
• InjuryMar 10, 2026Device 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 BETWEEN 2021 - 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO COMPONENT DISSOCIATION AND UNEXPLAINED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Pain

  MAUDE report 24560485 ↗
• 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 AUG. 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 24342226 ↗
• 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) 2023, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 24197666 ↗
• 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, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 24197584 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, REVISION SURGERY WAS PERFORMED. 2 STAGE PROCEDURE AS LIKELY TO BE INFECTED. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2022, WITH ASCEND FLEX AND REVERSE II IMPLANTS. ALL IMPLANTS WERE REMOVED AND PICTURED. A CEMENT SPACER WAS PLACED IN. IT WAS FURTHER REPORTED, THE PATIENT HAD PAIN AND SURGEON ORDERED X-RAYS (THESE WERE ATTACHED IN MY SUBMISSION) AND SURGEON NOTICED BONE REABSORPTION. DID NOT EXPECT INFECTION AS NO PATHOLOGY TESTS INDICATED IT. HOWEVER IN REVISION SURGEON THERE WAS STRONG EVIDENCE OF INFECTION WITH PUS AND INFECTED TISSUE.

  Patient problems: Implant Pain; Osteolysis; Unspecified Infection

  MAUDE report 23870834 ↗
• 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 23334483 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT; A PATIENT WAS BOOKING IN FOR A REVISION PROCEDURE DUE TO ONGOING PAIN AND STIFFNESS. DURING THE DISSECTION LOTS OF FLUID/ PUSS WAS SEEN AND THE DECISION WAS MADE TO DO A 2 STAGE PROCEDURE TO CLEAR THE INFECTION. ANOTHER REVISION PROCEDURE WILL BE NEEDED AFTER THE INFECTION HAS CLEARED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain; Unspecified Infection

  MAUDE report 23083921 ↗
• 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 22735480 ↗
• InjuryMay 26, 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 AND DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Subluxation

  MAUDE report 22084119 ↗
• InjuryMar 13, 2025Osseointegration Problem; Osseointegration 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 ASEPTIC LOOSENING HUMERUS WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21594800 ↗
• InjuryMar 6, 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 TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2013 ¿ (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024, A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s)

  MAUDE report 21533758 ↗
• 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 21036826 ↗
• 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 20508261 ↗
• InjurySep 12, 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 APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2022 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 20201308 ↗
• InjuryAug 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  TSR WAS DISLOCATING. INSERT AND TRAY REMOVED, AND JOINT TRIALED WITH ALTERNATIVE IMPLANTS. A +6MM TRAY AND RETENTIVE POLY USED TO IMPROVE STABILITY.

  Patient problems: Joint Dislocation

  MAUDE report 19962124 ↗
• InjuryAug 6, 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 APRIL 2012 ¿ MAY 2022. 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. REVISION PROCEDURE TYPE: STAGE 1 OF 2 STAGE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 19919036 ↗
• InjuryJul 25, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  FLEX REVIVE STUDY. PATIENT: (B)(6). AS REPORTED: REVISION SURGERY PERFORMED ON (B)(6) 2024. DUE TO POST-OPERATIVE COMPLICATION: INSTABILITY/DISLOCATION. ADVERSE EVENT IN DETAILS : "CALLED ON 04 JUN 24, DISLOCATED ON (B)(6) 2024. SUBSEQUENT RECURRENT DISLOCATION. SCHEDULED FOR REVISION ON (B)(6) 2024." TREATMENT/ MEDICATION: YES. MEDICATION: OVER THE COUNTER ANTI-INFLAMMATORY. OTHER ACTION TAKEN: YES, SLING AND REVISION SURGERY ON (B)(6) 2024.

  Patient problems: Inflammation; Joint Dislocation

  MAUDE report 19833881 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT UNDERWENT PRIMARY RIGHT SHOULDER REPLACEMENT, ON (B)(6) 2024, AT (B)(6) HOSPITAL, QLD. PATIENT UNDERWENT REVISION OF THIS SHOULDER JOINT, YESTERDAY ON (B)(6) 2024), AFTER A SHORT HISTORY OF PAIN, SWELLING, REDNESS OVER SURGICAL SITE. PT PRESENTED AT (B)(6) HOSPITAL LAST FRIDAY ON (B)(6) 2024), WITH THESE SIGNS, AND FEELING GENERALLY UNWELL. CLINICAL DIAGNOSIS OF INFECTION, AS PER SURGEON'S COMMENTS YESTERDAY (SAME SURGEON). REVISION SURGERY YESTERDAY CARRIED OUT AT (B)(6) HOSPITAL. WOUND OPENED, MULTIPLE SPECIMENS TAKEN AS SEVERAL IMPLANTS WERE REMOVED AND REPLACED, AFTER COPIOUS LAVAGE / DEBRIDEMENT. HUMERAL TRAY AND POLY REPLACED. ASCEND FLEX STEM LEFT INSITU (APPEARED TO BE SOLIDLY FIXED). GLENOSPHERE REPLACED. 3 OF THE 4 BASEPLATE SCREWS REPLACED (4TH SCREW UNABLE TO BE REMOVED). BASEPLATE LEFT INSITU - VERY SLIGHT MOVEMENT OF BASEPLATE NOTED, AFTER THE 3 X SCREWS REMOVED, BUT SURGEON DECIDED TO LEAVE IT INSITU, AND AFTER THE NEW SCREWS WERE IMPLANTED, THE BASEPLATE APPEARED SOLIDLY FIXED."

  Patient problems: Erythema; Implant Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 19804413 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PT UNDERWENT PRIMARY RIGHT REVERSE SHOULDER REPLACEMENT, ON (B)(6) 2024. PT EXPERIENCED RECENT HISTORY OF PAIN, SWELLING, IN RIGHT PROSTHETIC SHOULDER JOINT. UNDERWENT REVISION ON (B)(6) 2024. MULTIPLE SPECIMENS TAKEN, TO DETERMINE IF INFECTION PRESENT - GLENOID COMPONENT, AND HUMERAL TRAY AND POLY REVISED. PT UNDERWENT A 2ND REVISION, ON (B)(6) 2024, DUE TO SIGNIFICANT SWELLING IN PROSTHETIC JOINT. WOUND OPENED, TO REVEAL LARGE COLLECTION OF HEMATOMA. NO OBVIOUS COLLECTION OF PUS. HUMERAL TRAY / POLY AGAIN REVISED, AS WELL AS THE GLENOSPHERE. MULTIPLE SPECIMENS AGAIN TAKEN. COPIOUS LAVAGE".

  Patient problems: Hematoma; Implant Pain; Swelling/ Edema

  MAUDE report 19723103 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PT UNDERWENT PRIMARY RIGHT REVERSE SHOULDER REPLACEMENT, ON (B)(6) 2024. PT EXPERIENCED RECENT HISTORY OF PAIN, SWELLING, IN RIGHT PROSTHETIC SHOULDER JOINT. UNDERWENT REVISION ON (B)(6) 2024. MULTIPLE SPECIMENS TAKEN, TO DETERMINE IF INFECTION PRESENT - GLENOID COMPONENT, AND HUMERAL TRAY AND POLY REVISED. PT UNDERWENT A 2ND REVISION, ON (B)(6), DUE TO SIGNIFICANT SWELLING IN PROSTHETIC JOINT. WOUND OPENED, TO REVEAL LARGE COLLECTION OF HEMATOMA. NO OBVIOUS COLLECTION OF PUS. HUMERAL TRAY / POLY AGAIN REVISED, AS WELL AS THE GLENOSPHERE. MULTIPLE SPECIMENS AGAIN TAKEN. COPIOUS LAVAGE".

  Patient problems: Hematoma; Implant Pain; Swelling/ Edema

  MAUDE report 19715963 ↗