MAUDE Adverse Event Report: Tornier Inc PERFORM 45% INSERT VE SZ3/4 39 MM +0; Prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented

Catalog Number	DWS2390
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: PERFORM 45% INSERT VE SZ3/4 39 MM +0
• Common Device Name: Prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented
• 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: 50934508
• Report Number: 0001649390-2026-01015
• Device Sequence Number: 9589294
• Product Code: PAO
• UDI-Device Identifier: 00846832078080
• UDI-Public: 00846832078080
• 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: DWS2390
• Device Lot Number: AI4793023
• 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