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

Catalog Number	115-3210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision occurred 3 weeks after the primary surgery for acute instability of unknown cause.No actual, implied, or suspect link to fx product.
Event or Problem Description
Revision occurred approximately 3 weeks after the primary surgery which occurred on (b)(6) 2024.No fall or other trauma reported.Revision occurred due to acute instability.32 mm centered glenosphere and 32 mm + 6 standard humeral cup explanted.These parts were replaced with a 40 mm eccentric glenosphere, 40 mm + 3 stability humeral cup, and 9 mm spacer.

• Brand Name: FX V135 REVERSE
• 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: 20159866
• Report Number: 3014128390-2024-00044
• Device Sequence Number: 17964833
• Product Code: PHX
• UDI-Device Identifier: 03701037309551
• UDI-Public: 03701037309551
• 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: 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): 09/06/2024

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: 115-3210
• Device Lot Number: U2825
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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: 102-0806 LOT: U1365
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown