MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED FULL WEDGE BP 15 DG DIA 29MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.
Event or Problem Description
Revision of failed perform reverse glenoid baseplate.Patient had sudden onset of pain after physical exertion.Failure of glenoid baseplate fixation into glenoid necessitated revision surgery.This was removal of the glenoid components and conversion of the humeral component to a hemi component.
Additional Manufacturer Narrative
Corrections: fda registration number was reported as 3000931034 - te (mtbonnot); correct input is 1649390 - te (bloomington), d3: manufacturer entity, g1: manufacturing site tornier inc, g1: reporting contact.
Event or Problem Description
Revision of failed perform reverse glenoid baseplate.Patient had sudden onset of pain after physical exertion.Failure of glenoid baseplate fixation into glenoid necessitated revision surgery.This was removal of the glenoid components and conversion of the humeral component to a hemi component.

• Brand Name: TORNIER PERFORM REVERSED FULL WEDGE BP 15 DG DIA 29MM
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18676925
• Report Number: 3000931034-2024-00046
• Device Sequence Number: 20389175
• Product Code: PHX
• UDI-Device Identifier: 00846832092147
• UDI-Public: 00846832092147
• 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 Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: DWJ515
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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