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

Catalog Number	105-3210
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• 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: 18913731
• Report Number: 3014128390-2024-00016
• Device Sequence Number: 6892476
• Product Code: PHX
• UDI-Device Identifier: 03701037309476
• UDI-Public: 03701037309476
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K192206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace,Notification
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 105-3210
• Device Lot Number: U0248
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2023
• 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
• Patient Sex: Unknown