MAUDE Adverse Event Report: TORNIER INC PERFORM 10 DEG 45% INSERT SZ1/2 39 MM +0; shoulder prosthesis, reverse configuration

Catalog Number	DWR1390
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and, if received, will be provided in the supplemental report.
Event or Problem Description
The procedure took place due to chronic dislocation.Once the surgeon got exposure, the tray and poly were removed and the poly had medial wear.

• Brand Name: PERFORM 10 DEG 45% INSERT SZ1/2 39 MM +0
• 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: 25217218
• Report Number: 0001649390-2026-00450
• Device Sequence Number: 9810540
• Product Code: PHX
• UDI-Device Identifier: 00846832084784
• UDI-Public: 00846832084784
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

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: DWR1390
• Device Lot Number: UNKNOWN
• Date Returned to Manufacturer: 05/04/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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