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

Catalog Number	105-0028
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient dislocated approximately 2 weeks after the prior revision for unknown causes.No actual, implied, or suspect link to fx product.
Event or Problem Description
Revision occurred on (b)(6) 2024, approximately 2 weeks after the prior revision on (b)(6) 2024.Primary surgery occurred on (b)(6) 2023.No fall or other trauma reported.Revision occurred due to dislocation of unknown cause.The first revision occurred for a similarly ambiguous reason.This second revision was a replacement of everything except the stem.Explant of 24 mm baseplate, 32 mm centered glenosphere, 32 mm + 3 stability humeral cup, 9 mm spacer, and 5 screws.Implant of 24 mm baseplate, 36 mm eccentric glenosphere, 36 mm + 3 stability humeral cup, 9 mm spacer, and 4 screws.

• 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: 18793393
• Report Number: 3014128390-2024-00012
• Device Sequence Number: 8297150
• Product Code: PHX
• UDI-Device Identifier: 03701037313305
• UDI-Public: 03701037313305
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K192799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 02/27/2024

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: 105-0028
• Device Lot Number: U0259
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2023
• 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: 105-3210 LOT: S1860; PART: 105-4514 LOT: P2358; PART: 108-4515 LOT: U0903; PART: 109-4530 LOT: U1232; PART: 202-0903 LOT: T1637; PART: 203-0007 LOT: U0331
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female