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

Catalog Number	105-3610
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	02/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient was revised after 2 months for infection and dislocation.No actual, implied, or suspect link to fx product.
Event or Problem Description
Patient was revised on (b)(6) 2024, approximately 2 months after the primary surgery which occurred on (b)(6) 2023.No fall or other trauma reported.Revision occurred due to recurring dislocations and infection at implant site.36 mm centered glenosphere, 36 mm + 9 standard humeral cup explanted.These parts were replaced with a 40 mm eccentric glenosphere, reverse adapter, and 40 mm + 6 humeral stability cup implanted.Incision and drainage performed for infection, antibiotic beads also applied.

• Brand Name: HUMERIS 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: 18837608
• Report Number: 3014128390-2024-00013
• Device Sequence Number: 7458264
• Product Code: PHX
• UDI-Device Identifier: 03701037300268
• UDI-Public: 03701037300268
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150488
• 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): 03/05/2024

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: 105-3610
• Device Lot Number: U1640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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: 313-0709 LOT: N1710.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Unknown