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

Catalog Number	105-3210
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision occurred after 20 months for pain at the implant site.No actual, implied, or suspect link to fx product.
Event or Problem Description
Revision occurred approximately 20 months after the primary surgery which occurred on (b)(6) 2022.No fall or other trauma reported.Revision occurred due to pain at implant site.32 mm centered glenosphere and 32 mm + 3 standard humeral cup explanted.These parts were replaced with a 32 mm eccentric glenosphere and 32 mm + 6 standard humeral cup.

• 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: 19752856
• Report Number: 3014128390-2024-00038
• Device Sequence Number: 6579536
• Product Code: PHX
• UDI-Device Identifier: 03701037309476
• UDI-Public: 03701037309476
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K192206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/16/2024

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 Expiration Date: 08/01/2026
• Device Catalogue Number: 105-3210
• Device Lot Number: S0540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2021
• 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: 102-0803 LOT: P1999.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Unknown