MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS DALLAS FXV135 REVERSED; REVERSE SHOULDER PROSTHESIS

Catalog Number	115-3610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was revised approximately 7 months after the primary surgery which occurred on (b)(6) 2023.No fall or other trauma reported.Patient dislocated for unknown reasons and was not able to move their arm.36 mm centered glenosphere and 36 mm + 9 humeral stability cup explanted.These parts were replaced with a 40 mm centered glenosphere, a 40 mm + 6 stability humeral cup, and a 9 mm spacer.
Additional Manufacturer Narrative
Patient revised after 7 months for dislocation of an unknown cause.No actual, implied, or suspect link to fx product.

• Brand Name: FXV135 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: 18435651
• Report Number: 3014128390-2024-00001
• Device Sequence Number: 7155342
• Product Code: PHX
• UDI-Device Identifier: 03701037300800
• UDI-Public: 03701037300800
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2024

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: 115-3610
• Device Lot Number: S1866
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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: 203-0909 LOT: S1048
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male