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

Model Number 107-4524

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 02/25/2022

Event Type  Injury  

Manufacturer Narrative

The event took place outside of the united states (in (b)(6)) and was associated with a product that is also cleared for the market within the united states.

Event Description

The patient was revised on (b)(6) 2022 due to fracture.Approximately 4 years and 1 month after the first surgery.The surgeon explanted 2 cortical screws lg 24mm.The surgeon implanted 1 diaphysial plate, 2 locked osteosynthesis screw, 1 standard screw, 2 locking screw.

• Brand Name: HUMELOCK II REVERSIBLE
• Type of Device: REVERSIBLE SHOULDER PROSTHESIS
• 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: 13937097
• MDR Text Key: 288090317
• Report Number: 3009532798-2022-00082
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037301951
• UDI-Public: 03701037301951
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K130759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/17/2022

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: 11/11/2022
• Device Model Number: 107-4524
• Device Catalogue Number: 107-4524
• Device Lot Number: L2647
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 03/29/2022
• 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