Shoulder iD DWJ604Recalls & reported problems
Tornier, Inc. · Primary Reversed Glenoid · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840338604279), received between Nov 11, 2025 and Jan 28, 2026 — classified as 3 injuries.
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
Patient problems
- Pain2
- Joint Impingement1
- Joint Laxity1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6). SHOULDER ID STUDY. PATIENT RETURNED FOR NEW ONSET OF SHOULDER PAIN, LEFT SHOULDER. PAIN STARTED AFTER 3 MONTH FOLLOW-UP AND WAS SIGNIFICANTLY WORSE ON (B)(6) 2025. UNCLEAR DIAGNOSIS AT TIME OF VISIT AND PATIENT WILL UNDERGO CT FOR FURTHER ASSESSMENT.
Patient problems: Pain
MAUDE report 24198262 ↗InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6) SHOULDER ID STUDY. THE PATIENT CALLED THE UTSW ORTHOPAEDIC SURGERY CLINIC IN FRISCO (B)(6) 2025 TO REPORT HE "ACCIDENTALLY PICKED UP A GALLON CONTAINER AND HELD IT FOR ABOUT 2 MINUTES." HE REPORTED INCREASING PAIN IN HIS LEFT SHOULDER WITH MOVEMENT. HE SAID HE FELT AS IF HE WAS "BACK TO SQUARE 1" AS PRIOR TO THE SHOULDER SURGERY. THE SURGEON ORDERED X-RAYS (B)(6) 2025 AND DETERMINED THEY "LOOKED GOOD" AND SHE ADVISED THE PATIENT TO REST THE SHOULDER.
Patient problems: Pain
MAUDE report 23838738 ↗InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6) SHOULDER ID STUDY (B)(6) 2025. POST-OPERATIVE ADVERSE EVENT: SCAPULAR NOTCHING NARRATIVE: PATIENT WAS FOUND TO HAVE A LOOSE HUMERAL COMPONENT IN THE SETTING OF EARLY SCAPULAR NOTCHING AT AN UNSCHEDULED VISIT 1.5 YEARS AFTER SURGERY.
Patient problems: Joint Impingement; Joint Laxity
MAUDE report 23525701 ↗
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 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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