MAUDE Adverse Event Report: TORNIER INC PERFORM 10 DEG 55% INSERT SZ3/4 39 MM +3; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWR4393
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	06/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
It was reported that the patient underwent a revision procedure due to suspected infection.During the procedure, the implant was cleaned, and the insert was removed and replaced.

• Brand Name: PERFORM 10 DEG 55% INSERT SZ3/4 39 MM +3
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 25736201
• Report Number: 0001649390-2026-00697
• Device Sequence Number: 21435748
• Product Code: PHX
• UDI-Device Identifier: 00846832085033
• UDI-Public: 00846832085033
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2026

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: DWR4393
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 07/07/2026
• 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 Sex: Unknown