MAUDE Adverse Event Report: FH INDUSTRIE ARROW; ARROW GLENOID INSERT S46

Catalog Number 265158

Device Problem Break (1069)

Patient Problem Implant Pain (4561)

Event Date 09/15/2020

Event Type  malfunction  

Event Description

Developed subscapularis failure port-op.A couple months ago, doing a knee push-up, felt a pop with increased pain and grinding.Y-ray showed eccentric humeral head.Surgery showed the polyethylene shell had broken off the "nipple"-like stem.

Manufacturer Narrative

Fh industrie procedures did not clearly define the rules for reporting incidents to fda when the devices were no longer being distributed into the us market.The vigilance officer at the time was unaware that these reporting rules had to be applied even to products that were no longer distributed in the united states and that were inactivated in the fda registration & listing database.The medwatch reports that were not filed are not connected to any recalls and had no impact on patient safety.A capa was opened to determine root cause and corrective action.

• Brand Name: ARROW
• Type of Device: ARROW GLENOID INSERT S46
• 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: el yazid aribi ; 6 rue nobel; quimper, 29000 ; FR 29000
• MDR Report Key: 17930129
• MDR Text Key: 325602239
• Report Number: 3003898228-2023-00011
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/21/2022
• Device Catalogue Number: 265158
• Device Lot Number: RH02381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• 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 Age: 57 YR
• Patient Sex: Male