MAUDE Adverse Event Report: TORNIER INC SHOULDER ID PRM REV GLENOID 25MM POST CENTERED 25MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ603
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
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.
Additional Manufacturer Narrative
The reported event could be confirmed, since ct-scans images were provided.A device inspection was not possible since the affected device was not returned.Since ct-scans images were provided, the opinion of the medical expert was sought and stated as follows: the ct-scan shows a correct placement and seating of the study device in subject (b)(6).No issues with the humeral component either.The subject is a female patient with a relatively low body mass (bmi 18.8), altogether a risk factor for these types of scapular stress fractures.The complaints of scapular (stress-) fractures in rsa typically start several weeks/months after the surgery, as was the case in this subject.The ct-scans show the subtle undisplaced stress fracture indeed.Based on investigation, the root cause was attributed to a patient related factor.The ct-scan shows a correct placement and seating of the devices.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: SHOULDER ID PRM REV GLENOID 25MM POST CENTERED 25MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23642356
• Report Number: 0001649390-2025-00853
• Device Sequence Number: 10160274
• Product Code: PHX
• UDI-Device Identifier: 00840338604286
• UDI-Public: 00840338604286
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DWJ603
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 52 KG