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

Catalog Number	204-0906
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision occurred approximately 6 weeks after the prior revision surgery which occurred on (b)(6) 2023.This was preceded by the primary surgery on (b)(6) 2023.No fall or other trauma reported.Revision occurred for dislocation of unknown cause.Revision was a total explant of an fx system with replacement by a competitor system.Explant includes: 40 mm + 6 stability humeral cup, 40 mm centered glenosphere, 9 mm spacer, 24 mm cementless baseplate, 36/16 system stem, 20 mm central screw, 30 mm standard screw, 20 mm locking screw (2), and 30 mm locking screw.
Additional Manufacturer Narrative
Patient revised two months after previous revision surgery.Revision was a total explant of fx product and replacement with competitor product.No actual, implied, or suspect link to fx product.

• 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: 18721748
• Report Number: 3014128390-2024-00010
• Device Sequence Number: 6311112
• Product Code: PHX
• UDI-Device Identifier: 03701037315439
• UDI-Public: 03701037315439
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K213117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2024

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 Catalogue Number: 204-0906
• Device Lot Number: T1668
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2023
• 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: 105-0028 LOT: T0760; PART: 105-4520 LOT: T1777; PART: 108-4520 LOT: P1954; PART: 108-4520 LOT: T1608; PART: 108-4530 LOT: T0979; PART: 109-4530 LOT: S0027; PART: 115-4010 LOT: S0188; PART: 203-0007 LOT: U0331; PART: 318-3616 LOT: T1673
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male