Shoulder iD DWJ603Recalls & reported problems
Tornier, Inc. · Primary Reversed Glenoid · Class 2 · Implant
- 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 00840338604286), received between May 16, 2024 and Dec 4, 2025 — classified as 7 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Device Dislodged or Dislocated1
- Loss of Osseointegration1
Patient problems
- Bone Fracture(s)2
- Pain2
- Embolism/Embolus1
- Fever1
- Hematoma1
- Implant Pain1
- Insufficient Information1
- Joint Dislocation1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryDec 4, 2025Loss of Osseointegration; Loss of Osseointegration
SUBJECT: (B)(6). SHOULDER ID STUDY. INFECTION - DEEP. SUBJECT WAS FOUND TO HAVE GLENOID BASEPLATE LOOSENING AND INFECTION AT UNSCHEDULED 6-MONTH POST-OPERATIVE VISIT.
Patient problems: Unspecified Infection
MAUDE report 23713807 ↗InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6) SHOULDER ID STUDY. SCAPULAR FRACTURE - ACROMIAL. PT BEGAN EXPERIENCING SEVERE LEFT SHOULDER PAIN STARTING AROUND (B)(6) 2025. CT COMPLETED ON (B)(6) 2025 SHOWED MINIMALLY DISPLACED FRACTURE OF THE ACROMION.
Patient problems: Bone Fracture(s); Pain
MAUDE report 23642356 ↗InjuryOct 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
SUBJECT: (B)(6). SHOULDER ID STUDY. (B)(6) 2025. INSTABILITY, ANTERIOR DISLOCATION. PATIENT WAS FOUND TO HAVE A POST-OPERATIVE ANTERIOR SHOULDER DISLOCATION UPON X-RAY AT INITIAL POST-OPERATIVE VISIT. SHE WAS REVISED ON (B)(6) 2025.
Patient problems: Joint Dislocation
MAUDE report 23300788 ↗InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "SUBJECT: (B)(6) STUDY: SHOULDER ID. PATIENT PRESENTED TO ED (B)(6) 2025 S/P GENERALIZED WEAKNESS (SLID TO FLOOR FROM CHAIR) AND FEVER AND WAS FOUND TO HAVE ACUTE PE [PULMONARY EMBOLISM]. PATIENT HOSPITALIZED AT OSU BEGINNING (B)(6) 2025. X-RAY OF R SHOULDER OBTAINED IN ED AND SHOWED INTACT HARDWARE WITHOUT COMPLICATION. (B)(6) 2025 - HEMATOMA - NARRATIVE: LEFT LOWER QUADRANT (LLQ) ABDOMINAL PAIN SECONDARY TO LARGE ACTIVE RECTUS SHEATH HEMATOMA IN THE SETTING OF NEW ANTICOAGULATION THERAPY. WARFARIN HELD AND REVERSED W/ VITAMIN K. PT REMAINS HOSPITALIZED. (B)(6) 2025: ACUTE DEEP VENOUS THROMBOSIS IN LEFT GASTROCNEMIUS VEINS. PT REMAINS HOSPITALIZED. OUTCOME: NOT RECOVERED/NOT RESOLVED".
Patient problems: Embolism/Embolus; Fever; Hematoma; Pain; Thrombosis/Thrombus
MAUDE report 21572495 ↗InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "SUBJECT: (B)(6). PT BEGAN EXPERIENCING CONSTANT SEVERE SHOULDER PAIN ON (B)(6) 2024. CT UNREMARKABLE. AS OF (B)(6) 2024. PATIENT STILL IS EXPERIENCING SHOULDER PAIN, BUT NO LONGER AS CONSTANT OR SEVERE."
Patient problems: Implant Pain
MAUDE report 21262260 ↗InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "SUBJECT: 003-011 SHOULDER ID STUDY. SCAPULAR FRACTURE - SCAPULAR SPINE (POST-OPERATIVE)".
Patient problems: Bone Fracture(s)
MAUDE report 21147064 ↗InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PRIMARY REVERSE PROCEDURE EMPLOYED TORNIER IMPLANTS, INCLUDING THE SHOULDER ID BASEPLATE AND PERFORM HUMERAL. THE OBSERVED BASEPLATE FAILURE IS ATTRIBUTED TO LIKELY OVER-LATERALIZATION, STEMMING FROM THE THICKNESS OF THE SHOULDER ID BASEPLATE AND A LATERALIZED GLENOSPHERE.
Patient problems: Insufficient Information
MAUDE report 19328768 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.