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

Model Number 311-0212

Device Problem Patient Device Interaction Problem (4001)

Event Date 07/07/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 299557769
• Report Number: 3009532798-2022-00125
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037301067
• UDI-Public: 03701037301067
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 311-0212
• Device Catalogue Number: 311-0212
• Device Lot Number: P0753
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization