MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS DALLAS FX V135 MINI REVERSED; REVERSE SHOULDER PROSTHESIS

Catalog Number	115-3210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision occurred approximately 10 weeks after the prior revision surgery which occurred on (b)(6) 2024.Primary surgery occurred on (b)(6) 2024.No fall or other trauma reported.Revision occurred due to dislocation of unknown cause.32 mm centered glenosphere and 32 mm + 9 humeral stability cup explanted.These were replaced with 36 mm centered glenosphere and a 36 mm + 3 humeral stability cup.
Additional Manufacturer Narrative
Revision occurred after 10 weeks for dislocation of unknown cause.No actual, implied, or suspect link to fx product.

• Brand Name: FX V135 MINI REVERSED
• Common Device Name: REVERSE SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SHOULDER SOLUTIONS DALLAS; 15920 addison road; addison TX 75001
• Manufacturer (Section G): FX SHOULDER SOLUTIONS DALLAS; 15920 addison road; addison TX 75001
• Manufacturer Contact: tristan mahler ; 15920 addison road; addison, TX 75001 ; 7137326920
• MDR Report Key: 20854399
• Report Number: 3014128390-2024-00063
• Device Sequence Number: 8776750
• Product Code: PHX
• UDI-Device Identifier: 03701037309551
• UDI-Public: 03701037309551
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2024

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: Health Professional
• Device Catalogue Number: 115-3210
• Device Lot Number: U2825
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PART: 102-1009 LOT: U1528
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female