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

Model Number 105-4010

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 12/28/2021

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 for infection on (b)(6) 2021.Approximately 2 months after the first surgery.The surgeon explanted 1 humelock stem, 1 centered glenosphere with screw, 1 humeral cup ø40+9, 1 glenoid baseplate, 1 post extension, 1 standard screw l25mm, 1 standard screw l35mm and 2 locking screw.The surgeon implanted 1 post extension, 1 glenoid baseplate, 2 locking screw, 2 standard screw, 1 eccentric glenosphere with screw, 1 humelock stem, 2 cortical screw and 1 humeral cup 135/145° ø40+9.

• Brand Name: HUMELOCK II REVERSED
• Type of Device: REVERSED 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: 13415776
• MDR Text Key: 284856645
• Report Number: 3009532798-2021-00268
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037300305
• UDI-Public: 03701037300305
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/01/2022

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 Model Number: 105-4010
• Device Catalogue Number: 105-4010
• Device Lot Number: P1594
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/29/2021
• Initial Date FDA Received: 02/01/2022
• 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