MAUDE Adverse Event Report: Tornier Inc TORNIER PERFORM REVERSED LATERALIZED GLENOSPHERE +3 DIA 39MM; Shoulder prosthesis, reverse configuration

Catalog Number	DWJ023
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "patients shoulder became unstable six months after initial rsa surgery so surgeon performed a revision surgery to exchange the 39mm glenosphere and 45% reverse poly insert.".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: TORNIER PERFORM REVERSED LATERALIZED GLENOSPHERE +3 DIA 39MM
• 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 ; +1(201)831-5000
• MDR Report Key: 50934359
• Report Number: 0001649390-2026-01014
• Device Sequence Number: 9509191
• Product Code: PHX
• UDI-Device Identifier: 00846832090389
• UDI-Public: 00846832090389
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: DWJ023
• Device Lot Number: AH6204019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/29/2026
• 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: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male