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

Catalog Number	116-5400
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	06/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision occurred after 21 days for infection.No actual, implied, or suspect link to fx product.
Event or Problem Description
Revision occurred approximately 3 weeks after the prior revision surgery which occurred on (b)(6) 2024, which was a removal of competitor product and a conversion to hemi.The first implantation of fx components occurred on (b)(6) 2023; before this was a primary implantation of a competitor system at an unknown date.The first revision of fx components occurred on (b)(6) 2024.No fall or other trauma reported.This latest revision occurred for infection.Offset head 54x21 and 5 mm spacer were explanted and replaced with an offset head 43x17 and double taper cone.

• Brand Name: HUMELOCK II 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: 19655931
• Report Number: 3014128390-2024-00037
• Device Sequence Number: 6596047
• Product Code: PHX
• UDI-Device Identifier: 03701037301012
• UDI-Public: 03701037301012
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191698
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2024

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: 07/01/2025
• Device Catalogue Number: 116-5400
• Device Lot Number: N0447
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2020
• 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: 106-4805 LOT: P0485.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male