MAUDE Adverse Event Report: TORNIER INC PERFORM 45% INSERT SZ1/2 36 MM +3; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWP1363
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Laxity (4526); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that, the insert dislodgement occurred possibly due to improper installation.The device was implanted on (b)(6) 2025, and revision surgery to remove the insert was performed on (b)(6) 2025.
Additional Manufacturer Narrative
The event could not be confirmed because the device was found to function as intended.The device inspection revealed the following the visual inspection of the returned reveals no signs of damage.Furthermore a functional test was performed with the returned complaint device in our split fixture.The device seated in the fixture without issue by following the surgical technique 3 impactions after applying some thumb pressure to the returned device.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on analysis of the returned component and provided information, the root cause was attributed to a user related issue.The most likely cause of the reported difficulty is due to the user not applying thumb pressure to the polyethylene component prior to impaction.The surgical technique instructs the user to apply hand pressure to begin to engage the locking mechanism.If any further information is provided the complaint report will be updated.
Event or Problem Description
It was reported that, the insert dislodgement occurred possibly due to improper installation.The device was implanted on (b)(6) 2025, and revision surgery to remove the insert was performed on (b)(6) 2025.

• Brand Name: PERFORM 45% INSERT SZ1/2 36 MM +3
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22382633
• Report Number: 0001649390-2025-00483
• Device Sequence Number: 17917385
• Product Code: PHX
• UDI-Device Identifier: 00846832084401
• UDI-Public: (01)00846832084401(11)240104(17)290104(21)6112AZ43
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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: DWP1363
• Device Lot Number: 6112AZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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: Required Intervention
• Patient Sex: Female