MAUDE Adverse Event Report: Tornier Inc TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM STERILE; Shoulder prosthesis, reverse configuration

Catalog Number	DWJ718
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "yesterday, the surgeon performed a revision for pt f g.The glenoid had become unstable and the entire perform+ construct (baseplate+post+peripheral screws+glenosphere) came out and rotated down.He removed the tray and liner from the humeral components, and due to the stem being well fixed, placed a cobolt-chrome head on instead making it a hemi construct.".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM STERILE
• 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: 50735216
• Report Number: 0001649390-2026-00929
• Device Sequence Number: 13420174
• Product Code: PHX
• UDI-Device Identifier: 00846832091225
• UDI-Public: 00846832091225
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: DWJ718
• Device Lot Number: AG7938025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 09/11/2026
• 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