MAUDE Adverse Event Report: FH INDUSTRIE ARROW; ARROW METALBACK HUM. INSERT D36 H00

Model Number 265141

Device Problem Material Separation (1562)

Patient Problem Failure of Implant (1924)

Event Date 02/14/2022

Event Type  malfunction  

Event Description

Uncoupling of the two humeral prosthetic parts, at a distance of 2 and a half months after fitting.Clinical consequence: hospitalization and surgical revision.

• Brand Name: ARROW
• Type of Device: ARROW METALBACK HUM. INSERT D36 H00
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer (Section G): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer Contact: cécilia hernoux ; 3 rue de la foret; heimsbrunn 68990 ; FR 68990
• MDR Report Key: 13869694
• MDR Text Key: 297963443
• Report Number: 3003898228-2022-00002
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 03661489651410
• UDI-Public: 03661489651410
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Pharmacist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 265141
• Device Lot Number: M02011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2021
• 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