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

Catalog Number	103-1003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision occurred 2 weeks after the prior revision, for a dislocation of unknown cause.No actual, implied, or suspect link to fx product.
Event or Problem Description
Revision occurred approximately 14 days after the previous revision surgery which occurred on (b)(6) 2024.Primary surgery occurred on (b)(6) 2024.The first revision surgery was for a patient fall.For this revision, no fall or other trauma reported.This revision occurred for dislocation of no known cause.36 mm + 3 humeral stability cup and 9 mm humeral spacer explanted.These parts were replaced with a 50x19 centered head and 24 mm eccentric adapter.Distributor confirms that this is a conversion to a hemi resulting in no humeral cup present in the system.Distributor confirms that no non-fx product was implanted for explanted.

• Brand Name: FX V135 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: 19096375
• Report Number: 3014128390-2024-00022
• Device Sequence Number: 7407998
• Product Code: PHX
• UDI-Device Identifier: 03701037309414
• UDI-Public: 03701037309414
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193394
• 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): 04/12/2024

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: 103-1003
• Device Lot Number: S2315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PART: 103-0007 LOT: U0720
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Unknown