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

Model Number	265141
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: 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
• Report Number: 3003898228-2022-00002
• Device Sequence Number: 4612909
• Product Code: KWT
• UDI-Device Identifier: 03661489651410
• UDI-Public: 03661489651410
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown