MAUDE Adverse Event Report: Tornier Inc PERFORM 45% INSERT SZ3/4 36 MM +0; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Catalog Number	DWP2360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
All implants were removed due to suspected infection.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: PERFORM 45% INSERT SZ3/4 36 MM +0
• Common Device Name: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer 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: 50042216
• Report Number: 0001649390-2026-00757
• Device Sequence Number: 16067595
• Product Code: KWS
• UDI-Device Identifier: 00846832084456
• UDI-Public: (01)00846832084456(11)250520(17)300520
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: DWP2360
• Device Lot Number: 7474BB035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/29/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2025
• 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: Male