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

Catalog Number 105-3210

Device Problem Inaccurate Information (4051)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

Product mixup occurred at packaging facility, which has been issued a scar to investigate the error and prevent re-occurance.Packaging facility completed their investigation and fx accepted their findings on 15-mar-24.

Event Description

A 40 mm centered glenosphere was present in 32 mm centered glenosphere packaging.Packaging information: ref 105-3210 lot: u0248.Item was 105-4010, a one-of-a-kind test part.No surgical delay, as another 32 mm glenosphere was available in the kit.A scar was issued to medical group under scar 24-08.Medical group's number is rec 23-10-008.Associated with nc 23-0656.Medical group's investigated was completed and accepted by fx on 15-mar-24.

• Brand Name: HUMELOCK REVERSED
• Type of Device: 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: 18913731
• MDR Text Key: 337777398
• Report Number: 3014128390-2024-00016
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037309476
• UDI-Public: 03701037309476
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 105-3210
• Device Lot Number: U0248
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1