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

Catalog Number	105-0128
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised on (b)(6) 2022 because the glenoid component loosened.The primary surgery was on (b)(6) 2022.Glenoid baseplate, 36 mm centered glenosphere, and 3 screws explanted.These parts were replaced with a 50 mm offset head and centered spacer.
Additional Manufacturer Narrative
Patient revised after 2 weeks for loosening of glenoid component.No actual, implied, or suspect link to fx product.

• Brand Name: HUMERIS 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: 18903678
• Report Number: 3014128390-2024-00015
• Device Sequence Number: 12742534
• Product Code: PHX
• UDI-Device Identifier: 03701037316870
• UDI-Public: 03701037316870
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K210790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 03/14/2024

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
• Device Catalogue Number: 105-0128
• Device Lot Number: S2266
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 105-4520 LOT: T1274; PART: 108-4515 LOT: S2284; PART: 108-4515 LOT: T0103; PART: 115-3610 LOT: T1033
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female