MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK 2; UNCEMENTED SHOULDER PROTHESIS

Model Number	311-0212
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event took place outside of united states (in france) and was associated with a product that also cleared for the market within united states.
Event or Problem Description
The patient was revised on (b)(6) 2022 due to infection, approximately 351 days after the first surgery.The surgeon explanted 1 stem, 1 glenosphere, 1 metaglene, 1 cup, 6 screws.The surgeon implanted 1 stem, 1 glenosphere, 1 cup, 4 screws.

• Brand Name: HUMELOCK 2
• Common Device Name: UNCEMENTED SHOULDER PROTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: ratsamy thevenin ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 15389160
• Report Number: 3009532798-2022-00125
• Device Sequence Number: 17569770
• Product Code: HSD
• UDI-Device Identifier: 03701037301067
• UDI-Public: 03701037301067
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2022

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
• Device Expiration Date: 10/01/2025
• Device Model Number: 311-0212
• Device Catalogue Number: 311-0212
• Device Lot Number: P0753
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown