MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS HUMELOCK II; ANATOMIC SHOULDER PROSTHESIS

Catalog Number	112-0000
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An incident occurred during a prosthesis implantation procedure in argentina: upon opening the implant box, it was found to be empty containing no implant, labels, or instructions for use.There were no consequences for the patient's health, other than a one-hour extension of the operating time.
Additional Manufacturer Narrative
The event took place outside the united states (in argentina) and was associated with a product that is also cleared for the market in the united states.

• Brand Name: HUMELOCK II
• Common Device Name: ANATOMIC SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SHOULDER SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SHOULDER SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: souad bedrane ; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 50869011
• Report Number: 3009532798-2026-00047
• Device Sequence Number: 10674530
• Product Code: HSD
• UDI-Device Identifier: 03701037300732
• UDI-Public: 03701037300732
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 112-0000
• Device Lot Number: W0663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown