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

Catalog Number	317-3614
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	04/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision occurred approximately 9 months after primary surgery for potential infection.No actual, implied, or suspect link to fx product.
Event or Problem Description
Revision occurred approximately 9 months after primary surgery, which occurred on (b)(6)2022.Revision occurred due to infection.The revision was a total explant of the system, including the stem, baseplate, 36 mm centered glenosphere, 36 mm + 9 standard humeral cup, and 4 screws.This system was replaced with a competitor's anti-biotic spacer to treat the infection.First notification of this revision was given by the representative on (b)(6) 2023, in pursuance of information regarding a subsequent revision for the same patient, involving an explant of the anti-biotic spacer and a replacement of an fx system.

• Brand Name: HUMELOCK 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: 18495830
• Report Number: 3014128390-2024-00003
• Device Sequence Number: 3554360
• Product Code: PHX
• UDI-Device Identifier: 03701037303757
• UDI-Public: 03701037303757
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 01/11/2024

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: 317-3614
• Device Lot Number: S0698
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2023
• Initial Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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: 103-0809 LOT: S1560; PART: 105-0025 LOT: T1184; PART: 105-3610 LOT: T0545; PART: 109-4520 LOT: T0112; PART: 109-4525 LOT: T0113; PART: 109-4530 LOT: S1883
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male