MAUDE Adverse Event Report: TORNIER INC SHOULDER ID PRM REV GLENOID 35MM POST CENTERED 29MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ608
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Muscle/Tendon Damage (4532)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
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.Narrative: patient called the clinic to report pain and a potential shoulder dislocation.He states he raised his arm overhead too quickly.After seeing the patient, the surgeon reported being concerned for either a deltoid strain or acromial stress fracture.The surgeon advised the patient to rest and return to the clinic in two weeks with new images, and she will further assess him at that time.
Event or Problem Description
Subject: (b)(6) shoulder id study.Narrative: patient called the clinic to report pain and a potential shoulder dislocation.He states he raised his arm overhead too quickly.After seeing the patient, the surgeon reported being concerned for either a deltoid strain or acromial stress fracture.The surgeon advised the patient to rest and return to the clinic in two weeks with new images, and she will further assess him at that time.Update received from clinical deparment on 24 mar 2026: post-operative adverse event description: inferior deltoid strain.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Since x-rays were provided, the opinion of the medical expert was requested and stated as following: the diagnosis of an inferior deltoid muscle strain is a clinical diagnosis and i suppose we follow that.The implants are well-positioned and well-fixated to the bone.The components of the total construct of the rtsa are well-aligned,no signs of subluxation/dislocation on these x-rays.A muscle injury can occur during sudden movements.The deltoid muscle must adapt to the mechanics of an rtsa.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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 35MM POST CENTERED 29MM
• 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: 24637893
• Report Number: 0001649390-2026-00281
• Device Sequence Number: 13208223
• Product Code: PHX
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/22/2026

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: DWJ608
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 06/22/2026
• 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: 89 YR
• Patient Sex: Male
• Patient Weight: 162 LB