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

Catalog Number	105-3613
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	08/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient revised approx.6 months after implantation date, as the surgeon noticed an infection at the implant site.Original 36 mm glenophere and 36 mm + 3 standard humeral cup explanted.These parts were replaced with 36 mm glenophere and 36 mm + 6 stability humeral cup.Infection is ongoing after revision.
Additional Manufacturer Narrative
Patient presented with an infection at the implant site approximately 6 months after the initial implantation.No actual, suspect, or implied link to fx product.

• Brand Name: HUMELOCK REVERSED
• Common Device Name: REVERSE SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SHOULDER SOLUTIONS DALLAS; 13465 midway rd; suite 100 & 101; dallas 75244
• Manufacturer (Section G): FX SHOULDER SOLUTIONS DALLAS; 13465 midway rd; suite 100 & 101; dallas TX 75244
• Manufacturer Contact: tristan mahler ; 13465 midway rd; suite 100 & 101; dallas, TX 75244 ; 7137326920
• MDR Report Key: 17950039
• Report Number: 3014128390-2023-00026
• Device Sequence Number: 20512118
• Product Code: PHX
• UDI-Device Identifier: 03701037300275
• UDI-Public: 03701037300275
• 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: 2023
• 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): 10/17/2023

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: 105-3613
• Device Lot Number: T0784
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2023
• Initial Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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: 103-0803 LOT: T1406
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male