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

Catalog Number	318-3210
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	08/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision occurred after 3 months due to infection.No actual, implied, or suspect link to fx product.
Event or Problem Description
Revision occurred approximately 3 months after the primary surgery, which occurred on (b)(6) 2024.No fall or other trauma reported.Revision was a total explant of fx product due to infection.32/10 system stem, 24 mm + 3 baseplate, 32 mm glenosphere, 32 mm + 3 standard humeral cup, and 5 screws explanted.These were replaced with an antibiotic spacer.

• Brand Name: FX V135 MINI 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: 20055390
• Report Number: 3014128390-2024-00043
• Device Sequence Number: 8118177
• Product Code: PHX
• UDI-Device Identifier: 03701037315132
• UDI-Public: 03701037315132
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K213117
• 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): 08/23/2024

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: 318-3210
• Device Lot Number: T2007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2023
• 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: 105-0029 LOT: U2612; PART: 105-4520 LOT:U1204; PART: 108-4515 LOT: U3251; PART: 108-4520 LOT: 2787; PART: 108-4535 LOT: P0691; PART: 115-3210 LOT: U2361; PART: 202-0803 LOT: U0072
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown