MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK REVERSED; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number 105-3610

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 12/07/2021

Event Type  Injury  

Event Description

The revision surgery was performed as the patient was experiencing instability on (b)(6) 2021.The glenoid baseplate (24mm), centered glenosphere (36mm), humeral cup (36/3) and cortical screw (26mm), were explanted except for the humelock reversed cementless stem (36/12).A glenoid baseplate (24mm), centered glenosphere (36mm), humeral cup (36/3), central screw (16mm) and locking screws (15mm, 2 each of 30mm and 35mm) were implanted.

• Brand Name: HUMELOCK REVERSED
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 13122132
• MDR Text Key: 283078131
• Report Number: 3014128390-2021-00072
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037300268
• UDI-Public: 03701037300268
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/30/2021

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 Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: 105-3610
• Device Catalogue Number: 105-3610
• Device Lot Number: M2334
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2021
• Distributor Facility Aware Date: 12/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female