Flex Shoulder System DWF391BRecalls & reported problems
Tornier · Class 2 · Implant
All models of FLEX SHOULDER SYSTEM (35)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03700386940682), received between Dec 19, 2018 and Dec 29, 2025 — classified as 7 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Device Dislodged or Dislocated3
- Positioning Failure1
Patient problems
- Unspecified Infection3
- Joint Dislocation2
- Failure of Implant1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryDec 29, 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THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2018 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Unspecified Infection
MAUDE report 23905579 ↗InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
POST-OPERATIVE COMPLICATION: INFECTION. RE-OPERATION WITHCOMPONENT CHANGE ON THE (B)(6) 2021 (NO INFORMATION REGARDING THE EXACT DEVICES REMOVED) IV ANTIBIOTICS, CEMENT ANTIBIOTIC SPACER ADDED.
Patient problems: Unspecified Infection
MAUDE report 12297955 ↗InjurySep 17, 2020Positioning Failure; Positioning Failure
THE DWF391B REVERSE INSERT DID NOT ENGAGE INTO THE REVERSE TRAY WHEN PUTTING TOGETHER THE DEFINITIVE IMPLANTS. SURGEON TRIED MULTIPLE TIMES TO ENGAGE THE POLY ONTO THE TRAY BUT THERE WAS ALWAYS A GAP BETWEEN POLY AND TRAY. BOTH TRAY AND POLY WERE DISCARDED AND NEW IMPLANTS USED AS SURGEON WAS NOT SURE WHAT COMPONENT T WAS CAUSING THE ISSUE.
Patient problems: Failure of Implant
MAUDE report 10545876 ↗InjuryNov 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
"(B)(6) 2019: THE FIRST SURGERY OF ASCEND FLEX RSA WAS PERFORMED. (B)(6) 2019: AFTER THE SURGERY, DISLOCATION OCCURRED IN THE AFFECTED AREA."
Patient problems: Joint Dislocation
MAUDE report 9278761 ↗InjurySep 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT UNDERWENT INITIAL RSA ON (B)(6) 2017. THE IMPLANTS USED WERE ASCEND FLEX STD PTC HUMERAL STEM (DWF603B), REVERSE INSERT (DWF362B), REVERSE TRAY (DWF520), REVERSED II DIA. 25 PRESS FIT POST BASE PLATE (DWD170) AND REV. II GLENOID SPHERE DIA. 25 BASE PLATE (DWD180). ON (B)(6) 2017, A DISLOCATION OCCURED AND REVISION SURGERY WAS PERFORMED. DURING THIS SURGERY, TRAY (DWF520), INSERT (DWF391B), AND SPHERE (DWH905) WERE NEWLY USED. IN 2019 (NO DATE), DISLOCATION OCCURRED AGAIN AND MANUAL REDUCTION WAS PERFORMED, BUT A REVISION SURGERY WAS TO BE PERFORMED AGAIN. (B)(6) 2019, REVISION SURGERY WAS PERFORMED: ASCEND FLEX: LONG PTC HUMERAL STEM 4B 132.5 ° 104MM (DWF614B), REVERSED INSERT 42MM (+) 9 B-12.5 (DWF425B), REV. II GLENOID SPHERE DIA. 25 BASEPLATE DIA. 42MM 10 TILTED SPHERE (DWD184), ASCEND FLEX REVERSED TRAY (+) 0 1.5MM (DWF510) WERE NEWLY REPLACED.
Patient problems: Joint Dislocation
MAUDE report 9079530 ↗InjuryDec 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
"IT WAS REPORTED THAT A PATIENT HAD AN INSTABILITY/DISLOCATION 2 MONTHS POST-OPERATIVE. SUBJECT ID: (B)(6)".
Patient problems: Patient Problem/Medical Problem
MAUDE report 8178392 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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