MAUDE Adverse Event Report: Tornier Inc TORNIER PERFORM REVERSED STANDARD GLENOSPHERE DIA 42MM; shoulder prosthesis, reverse configuration

Catalog Number	DWJ014
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	07/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent revision surgery due to painful hardware and a suspected loose baseplate.
Additional Manufacturer Narrative
Additional information has been requested and, if received, will be provided in a supplemental report.

• Brand Name: TORNIER PERFORM REVERSED STANDARD GLENOSPHERE DIA 42MM
• 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: 50412879
• Report Number: 0001649390-2026-00876
• Device Sequence Number: 13038421
• Product Code: PHX
• UDI-Device Identifier: 00846832090358
• UDI-Public: 00846832090358
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K190402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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: DWJ014
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2026
• 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