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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 2 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 1 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

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

All shoulder prosthesis, reverse configuration devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.