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

Catalog Number	115-3613
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision occurred approximately 8 weeks after the prior revision which occurred on (b)(6) 2024.The prior revision occurred for non-compliance.The primary surgery occurred on (b)(6) 2023.No fall or other trauma reported.This revision occurred for a dislocation of unknown cause.36 mm centered glenosphere, 36 mm + 9 stability humeral cup, and 3 locking screws explanted.These parts were explanted and replaced with a 40 mm eccentric glenosphere, 40 mm + 6 stability humeral cup, 9 mm spacer, and 3 locking screws.
Additional Manufacturer Narrative
Revision occurred 2 months after the primary surgery which occurred due to dislocation of unknown cause.No actual, implied, or suspect link to fx product.

• Brand Name: FX V135 REVERSED
• Common Device Name: REVERSE SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SHOULDER SOLUTIONS DALLAS; 15920 addison road; addison
• 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: 19524129
• Report Number: 3014128390-2024-00032
• Device Sequence Number: 8412310
• Product Code: PHX
• UDI-Device Identifier: 03701037300817
• UDI-Public: 03701037300817
• Combination Product (Y/N): N
• 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): 06/12/2024

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: 115-3613
• Device Lot Number: S0817
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 108-4520 LOT: U0651; PART: 108-4525 LOT: U0366; PART: 108-4525 LOT: U0652; PART: 203-0809 LOT: S0574
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Unknown