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

Catalog Number	318-3212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Second revision occurred approximately 10 months after the first revision surgery due to infection.No complaint related to fx product.
Event or Problem Description
Second revision occurred on (b)(6) 2026, approximately 10 months after the first revision in (b)(6) 2025.The primary surgery happened on (b)(6) 2025.No fall or other trauma reported.Based on comparing usage forms fx v135 stem ta6v ø32/12 cementless ti/ha, humeral cup standard pe/ta6v ø36/+3, humelock reversed centered glenosphere w/ screw cocr/ta6v 10° tilt ø36mm, humelock reversed ta6v cementless glenoid baseplate w/ screw ti/ha ø24mm, +3mm lateralized, central screw ta6v ø4.5mm l.20mm, standard screw ta6v ø4.5mm l.20mm, standard screw ta6v ø4.5mm l.35mm and two locking screw ta6v ø4.5mm l.35mm was explanted in may 2025 due to infection and replaced with antibiotic spacer.The antibiotic spacer was explanted, and replaced with fx v135® humelock stem ta6v ø32/10 l.120mm cementless ti/ha, humeral cup stability pe/ta6v ø36/+3, humelock reversed centered glenosphere w/ screw cocr/ta6v 10° tilt ø36mm, humelock reversed ta6v cementless glenoid baseplate w/peg ti/ha ø24mm, +3mm lateralized, post extension ta6v +06mm cementless ti/ha, locking screw ta6v ø4.5mm l.15mm, locking screw ta6v ø4.5mm l.30mm, standard screw ta6v ø4.5mm l.30mm, cortical screw ta6v ø4.5mm l.28mm and cortical screw ta6v ø4.5mm l.30mm on (b)(6) 2026.

• Brand Name: FX V135
• 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: seenath kabeer ; 15920 addison road; addison, TX 75001 ; 7137326920
• MDR Report Key: 25070409
• Report Number: 3014128390-2026-00012
• Device Sequence Number: 10738524
• Product Code: PHX
• UDI-Device Identifier: 00840452403642
• UDI-Public: 840452403642
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K2131177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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
• Device Catalogue Number: 318-3212
• Device Lot Number: V1133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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: 103-0803 LOT: V0604; PART: 105-0029 LOT: V2113; PART: 105-3610 LOT: V0344; PART: 105-4520 LOT: V0872; PART: 108-4535 LOT: V0899; PART: 108-4535 LOT: V1168; PART: 109-4520 LOT: V1954; PART: 109-4535 LOT: V1960
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown